BS en Iso 80601-2-72-2015 PDF

BS EN ISO 80601-2-72:2015
BSI Standards Publication
Medical electrical equipment

Part 2-72: Particular requirements for
basic safety and essential performance of
home healthcare environment ventilators
for ventilator-dependent patients
BS EN ISO 80601-2-72:2015 BRITISH STANDARD
National foreword
This British Standard is the UK implementation of EN ISO
80601-2-72:2015. It supersedes BS EN ISO 10651-2:2009, which
is withdrawn.
The UK participation in its preparation was entrusted to Technical
Committee CH/121/9, Lung Ventilators & Related Equipment.
A list of organizations represented on this committee can be
obtained on request to its secretary.
This publication does not purport to include all the necessary
provisions of a contract. Users are responsible for its correct
application.
© The British Standards Institution 2015.
Published by BSI Standards Limited 2015
ISBN 978 0 580 79154 3
ICS 11.040.10
Compliance with a British Standard cannot confer immunity from
legal obligations.
This British Standard was published under the authority of the
Standards Policy and Strategy Committee on 30 September 2015.
Amendments/corrigenda issued since publication
Date Text affected
EUROPEAN STANDARD EN ISO 80601-2-72
NORME EUROPÉENNE
EUROPÄISCHE NORM September 2015
ICS 11.040.10 Supersedes EN ISO 10651-2:2009
English Version
Medical electrical equipment - Part 2-72: Particular

requirements for basic safety and essential performance of
home healthcare environment ventilators for ventilator-
dependent patients (ISO 80601-2-72:2015)
Appareils électromédicaux - Partie 2-72: Exigences Medizinische elektrische Geräte - Teil 2-72: Besondere
particulières pour la sécurité de base et les Festlegungen für die Sicherheit einschließlich der
performances essentielles des ventilateurs utilisés wesentlichen Leistungsmerkmale von
dans l'environnement des soins à domicile pour les Heimbeatmungsgeräten für vom Gerät abhängige
patients ventilo-dépendants (ISO 80601-2-72:2015) Patienten (ISO 80601-2-72:2015)
This European Standard was approved by CEN on 7 May 2015.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-72:2015 E
worldwide for CEN national Members.
BS EN ISO 80601-2-72:2015
EN ISO 80601-2-72:2015 (E)
European foreword
This document (EN ISO 80601-2-72:2015) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215
“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2016, and conflicting national standards shall
be withdrawn at the latest by September 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 10651-2:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 80601-2-72:2015 has been approved by CEN as EN ISO 80601-2-72:2015 without any
modification.
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BS EN ISO 80601-2-72:2015
EN ISO 80601-2-72:2015 (E)
Annex ZA
(informative)
Relationship between this Document and

the Essential Requirements of EU Directive 93/42/EEC
This Document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association to provide a means to conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the
laws of the Member States concerning medical devices” (Medical Device Directive).
Once this document is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with the
clauses of this document given in Table ZA.1, within the limits of the scope of this document, a
presumption of conformity with the corresponding Essential Requirements of that Directive and
associated EFTA regulations.
Table ZA.1 — Correspondence between this Document and Directive 93/42/EEC
Clause/subclause Corresponding essential Qualifying remarks/notes

of this Document requirement of
Directive 93/42/EEC
201.11.6.4, 201.11.6.6 7.2 Only the parts of ER 7.2 relating to
safety in use for the patient are
addressed.
201.11.6.4, 201.11.6.6 7.3 Only the part of the first sentence
relating to design is addressed.
201.11.6.4 7.5
201.11 7.6
201.11.6.6, 201.11.6.7 8.1 The part of ER 8.1 relating to easy
handling is not addressed.
201.11.6.7 8.4 Validated processes for sterilization
are required via the normative
references to ISO 11135-1,
ISO 11137-1 and ISO 17665-1.
201.4.6, 201.4.11, 201.7.2.4.101, 9.1
201.7.2.13.101, 201.7.2.17.101,
201.7.2.101, 201.7.9.2.2.101,
201.7.9.2.14.101, 201.12.1.102,
201.12.1.103, 201.16, 201.101,
201.102, 201.106
201.4.11.101, 201.9, 202, 206, 211 9.2 The 4th indent of ER 9.2 is not
addressed.
201.11 9.3
201.12.1, 201.102 10.1 The part of ER 10.1 relating to
stability is not addressed.
201.7, 201.12.1, 206, 208 10.2
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BS EN ISO 80601-2-72:2015
EN ISO 80601-2-72:2015 (E)

Directive 93/42/EEC
201.7.4.3 10.3
201.14 12.1
201.14 12.1 a)
202 12.5
201.8 12.6
201.9 12.7.1
201.9 12.7.2
201.9 12.7.3
201.8, 201.15, 201.101.1, 201.101.2 12.7.4
201.11 12.7.5
201.12.1 12.8.1 Only the protection of the patient is
covered.
201.12.4 12.8.2 Only the first sentence of ER 12.8.2
is covered.
201.7, 206 12.9
201.7, 201.11.6.4 13.1
201.7.2.3, 201.7.2.13.101, 13.2
201.7.2.17.101, 201.7.2.101, 201.8,
201.9, 201.11.6.4
201.7.9.1 13.3 a)
201.7.2.17.101 13.3 b)
201.7, 201.7.2.17.101 a) 13.3 c)
201.7.2.17.101 13.3 d) Is only covered if the batch number
is preceded by the word LOT.
201.7.2.17.101 13.3 f)
201.7.2.101 a), 211 13.3 i)
201.7.2.101 b), 201.7.2.101 d), 211 13.3 j)
201.7.2.101 b) 13.3 k)
201.7, 201.7.2.17.101 a) 13.3 m) Presumption of conformity is only
provided if one of the symbols 5.21
to 5.24 are utilized, as applicable.
201.7.9.1, 201.7.9.2, 201.16 13.6 a)
201.7.9.2.5.101 13.6 b)
201.7.9.2.14.101, 201.16, 201.102 13.6 c)
201.7, 201.7.9.2.8.101, 13.6 d)
201.7.9.2.13.101, 201.16
201.16 13.6 f)
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BS EN ISO 80601-2-72:2015
EN ISO 80601-2-72:2015 (E)

Directive 93/42/EEC
201.7.9.2.1.101, 201.7.9.2.12, 13.6 h)
201.16, 211
201.7 13.6 i)
211 13.6 k)
211 13.6 l)
211 13.6 n)
211 13.6 p)
WARNING Other requirements and other EU Directives may be applicable to the products falling
within the scope of this European Standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on
Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the
relevant essential requirements of Directive 2006/42/EC on Machinery to the extent to which they are
more specific than those of Directive 93/42/EEC along with the corresponding clauses of this European
Standard. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive
and thus does not provide presumption of conformity for the machinery directive.
Table ZA.2 — Relevant Essential Requirements from Directive 2006/42/EC on machinery that
are addressed by this Document (according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) EHSR of 2006/42/EC Qualifying remarks/Notes
of this EN
— 1.1.4 This relevant EHSR is not covered by
this standard.
201.12.1, 201.12.102, 201.12.103 1.2.2
201.7.2.101 c), 201.7.2.101 d), 1.5.4
201.101
— 1.6.2 This relevant EHSR is not covered by
this standard
201.8 1.6.3
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BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Contents Page
Foreword .................................................................................................................................................................. vii
Introduction ................................................................................................................................................................... ix

201.1 Scope, object and related standards....................................................................................................1
201.1.1 *Scope ............................................................................................................................................................1
201.1.2 Object .............................................................................................................................................................2
201.1.3 Collateral standards ..................................................................................................................................2
201.1.4 Particular standards .................................................................................................................................2
201.2 Normative references ...............................................................................................................................3
201.3 Terms and definitions ..............................................................................................................................5
201.4 General requirements ..............................................................................................................................7
201.4.3 ESSENTIAL PERFORMANCE ..............................................................................................................................7
201.4.3.101 *Additional requirements for ESSENTIAL PERFORMANCE .............................................................8
201.4.6 *ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT.........................................................8
201.4.10.2 *SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS..............................................................................8
201.4.11.101 *Additional requirements for pressurized gas input ..........................................................9
201.4.11.101.1 Overpressure requirement ......................................................................................................9
201.4.11.101.2 Compatibility requirement .......................................................................................................9
201.5 General requirements for testing of ME EQUIPMENT...................................................................... 10
201.5.101 *Additional requirements for general requirements for testing of ME EQUIPMENT ......10
201.5.101.1 VENTILATOR test conditions ............................................................................................................. 10
201.5.101.2 *Gas flowrate and leakage specifications ................................................................................ 10
201.5.101.3 *VENTILATOR testing errors ............................................................................................................ 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .............................................................................. 10
201.7 ME EQUIPMENT identification, marking and documents ............................................................... 10
201.7.2.3 *Consult ACCOMPANYING DOCUMENTS ..................................................................................................... 10
201.7.2.4.101 Additional requirements for ACCESSORIES .......................................................................... 11
201.7.2.13.101 Additional requirements for physiological effects ....................................................... 11
201.7.2.17.101 Additional requirements for protective packaging ...................................................... 11
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts .................................................................................................................................. 11
201.7.4.2 Control devices ......................................................................................................................................... 12
201.7.4.3 *Units of measurement ......................................................................................................................... 12
201.7.9.1 Additional general requirements ...................................................................................................... 12
201.7.9.2 Insructions for use.................................................................................................................................12
201.7.9.2.1.101 Additional general requirements ........................................................................................ 12
201.7.9.2.1.102 Additional general requirements ........................................................................................ 13
201.7.9.2.2.101 *Additional requirements for warnings and safety notices ...................................... 13
201.7.9.2.8.101 *Additional requirements for start-up PROCEDURE ........................................................ 14
201.7.9.2.9.101 *Additional requirements for operating instructions ................................................. 15
201.7.9.2.9.101.1 *LAY OPERATOR operating instructions ............................................................................. 15
201.7.9.2.9.101.2 *Supervising clinician operating instructions ............................................................. 15
201.7.9.2.12 Cleaning, disinfection, and sterilization .................................................................................... 16
© ISO 2015 – All rights reserved iii
ISO 80601-2-72:2015(E)
BS EN ISO 80601-2-72:2015
201.7.9.2.13.1 01 Additional requirements for maintenance.....................................................................17
201.7.9.2.14.101 *Additional requirements for ACCESSORIES, supplementary equipment, used
material ...................................................................................................................................................... 17
201.7.9.3.1.101 *Additional general requirements ..................................................................................... 17
201.7.9.3.101 Additional requirements for the technical description .............................................. 18
201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................................ 18
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS ........................... 18
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement ............ 18
201.9.4.4 Grips and other handling devices ..................................................................................................... 18
201.9.6.2.1.101 Additional requirements for audible acoustic energy ................................................ 18
201.10 Protection against unwanted and excessive radiation HAZARDS ............................................ 19
201.11 Protection against excessive temperatures and other HAZARDS............................................. 19
201.11.1.2.2 *APPLIED PARTS not intended to supply heat to a PATIENT.....................................................19
201.11.6.4 Leakage ................................................................................................................................................. 20
201.11.6.6 *Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM ................................................... 20
201.11.6.7 Sterilization of ME EQUIPMENT or ME SYSTEM ............................................................................... 21
201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT......................................... 21
201.11.8.101 Additional requirements for interruption of the power supply / SUPPLY
MAINS to ME EQUIPMENT ............................................................................................................................ 21
201.12 *Accuracy of controls and instruments and protection against hazardous outputs ......... 21
201.12.1 Accuracy of controls and instruments ............................................................................................ 21
201.12.1.101 Breath types................................................................................................................................ 22
201.12.1.102 Volume-controlled breath type ........................................................................................... 22
201.12.1.103 Pressure-controlled breath type......................................................................................... 25
201.12.1.104 DELIVERED VOLUME MONITORING EQUIPMENT .......................................................................... 28
201.12.4 Protection against hazardous output .............................................................................................. 29
201.12.4.4 Incorrect output ................................................................................................................................ 29
201.12.4.101 Oxygen monitor ......................................................................................................................... 29
201.12.4.102 *Measurement of AIRWAY PRESSURE ...................................................................................... 30
201.12.4.103 *Measurement of expired volume and low-volume ALARM CONDITIONS .................. 30
201.12.4.104 *Expiratory end-tidal CO2 MONITORING EQUIPMENT .......................................................... 31
201.12.4.105 *MAXIMUM LIMITED PRESSURE PROTECTION DEVICE ................................................................ 31
201.12.4.106 High-pressure ALARM CONDITION and PROTECTION DEVICE ............................................... 31
201.12.4.107 *Obstruction ALARM CONDITION .............................................................................................. 32
201.12.4.108 *Partial-occlusion ALARM CONDITION .................................................................................... 32
201.12.4.109 Hypoventilation ALARM CONDITION ........................................................................................ 32
201.12.4.110 Continuing positive-pressure ALARM CONDITION .............................................................. 33
201.12.4.111 *Leakage ALARM CONDITION ...................................................................................................... 33
201.12.101 *Protection against accidental adjustments ........................................................................... 33
201.13 HAZARDOUS SITUATIONS and fault conditions.................................................................................... 33
201.13.2.101 *Additional specific SINGLE FAULT CONDITIONS ................................................................... 33
201.13.101 Failure of one gas supply to a VENTILATOR ................................................................................. 34
201.13.102 *Independence of ventilation control function and related RISK CONTROL
measures .................................................................................................................................................... 34
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ....................................................................... 34
201.14.1 General ....................................................................................................................................................... 34
201.15 Construction of ME EQUIPMENT ............................................................................................................. 34
201.15.101 Mode of operation ............................................................................................................................. 34
201.15.102 ACCESSORY pre-use check ................................................................................................................. 34
201.15.103 Integrated dual-limb VBS ................................................................................................................ 34
iv © ISO 2015 – All rights reserved

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
201.16 ME SYSTEMS .................................................................................................................................................. 35

201.16.1.101 Additional general requirements for ME SYSTEMS ........................................................... 35
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................................ 35
201.101 Gas connections ....................................................................................................................................... 35
201.101.1 Connection to the MEDICAL GAS PIPELINE SYSTEM ......................................................................... 35
201.101.2 VBS connectors .................................................................................................................................... 35
201.101.2.1 *General ................................................................................................................................................ 35
201.101.2.2 Other named ports ............................................................................................................................ 35
201.101.2.2.1 PATIENT-CONNECTION PORT .............................................................................................................. 35
201.101.2.2.2 GAS OUTPUT PORT and GAS RETURN PORT....................................................................................... 35
201.101.2.2.3 *MANUAL VENTILATION PORT ............................................................................................................ 36
201.101.2.2.4 FLOW-DIRECTION-SENSITIVE COMPONENTS ...................................................................................... 36
201.101.2.2.5 ACCESSORY port .................................................................................................................................. 36
201.101.2.2.6 Monitoring probe port .................................................................................................................. 36
201.101.2.2.7 Gas EXHAUST PORT ............................................................................................................................. 36
201.101.2.2.8 Oxygen inlet port ............................................................................................................................ 36
201.102 Requirements for the VBS and ACCESSORIES ...................................................................................... 37
201.102.1 *General ................................................................................................................................................ 37
201.102.2 Labelling ............................................................................................................................................... 37
201.102.3 Breathing tubes .................................................................................................................................. 37
201.102.4 *Humidification .................................................................................................................................. 37
201.102.4.1 HUMIDIFIER ............................................................................................................................................. 37
201.102.4.2 HEAT AND MOISTURE EXCHANGER (HME) ............................................................................................ 37
201.102.5 BREATHING SYSTEM FILTERS (BSF) ...................................................................................................... 37
201.102.6 VENTILATOR BREATHING SYSTEMS ....................................................................................................... 38
201.102.6.1 Leakage from VBS ............................................................................................................................... 38
201.102.6.2 *Non-invasive ventilation ............................................................................................................... 38
201.103 *Spontaneous breathing during loss of power supply ............................................................... 38
201.104 *Training ....................................................................................................................................................38
201.105 *Indication of duration of operation ................................................................................................ 39
201.106 FUNCTIONAL CONNECTION ........................................................................................................................... 39
201.106.1 General .................................................................................................................................................. 39
201.106.2 *Connection to an electronic health record ............................................................................... 39
201.106.3 *Connection to a DISTRIBUTED ALARM SYSTEM ................................................................................ 39
201.106.4 Connection for remote control ..................................................................................................... 39
201.107 Display loops ............................................................................................................................................. 39
201.107.1 Pressure-volume loops .................................................................................................................... 39
201.107.2 Flow-volume loops ............................................................................................................................ 39
201.108 POWER SUPPLY CORDS ................................................................................................................................. 40
201.109 VENTILATOR security ................................................................................................................................ 40
202 Electromagnetic disturbances – Requirements and tests ........................................................ 40
202.4.3.1 *Compliance criteria .............................................................................................................................. 40
202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS ........................................... 40
202.8.1.101 Additional general requirements ................................................................................................ 41
206 Usability ...................................................................................................................................................... 41
© ISO 2015 – All rights reserved v

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems ................................................................................... 42
208.6.8.3.101Additional requirements for global indefinite ALARM SIGNAL inactivation states ..... 42
208.6.8.4.101 *Additional requirements for termination of ALARM SIGNAL inactivation .................. 42
208.6.12.101 *Additional requirements for ALARM SYSTEM logging ........................................................ 42
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment ................................................................................... 43
211.8.4.101 *Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT ............................................................................................................................................. 43
211.10.1.1 General requirements for mechanical strength ........................................................................ 44

Annex C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS .................................................................................................................................................. 45
Annex D (informative) Symbols on marking ...................................................................................................... 52

Annex AA (informative) Particular guidance and rationale ......................................................................... 53
Annex BB (informative) Data interface requirements ................................................................................... 72
Annex CC (informative) Reference to the Essential Principles .................................................................... 79
Annex DD (informative) Alphabetized index of defined terms used in this particular
standard ..................................................................................................................................................... 81
Bibliography ................................................................................................................................................................ 85
vi © ISO 2015 – All rights reserved

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national

standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non‐governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword ‐ Supplementary information.
The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee IEC/TC 62,
Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment.
This first edition of ISO 80601‐2‐72 cancels and replaces the second edition of ISO 10651‐2:2004. This
edition of ISO 80601‐2‐72 constitutes a major technical revision of ISO 10651‐2:2004 and includes an
alignment with the third edition of IEC 60601‐1 and the second edition of IEC 60601‐1‐11.
The most significant changes are the following modifications:
— extending the scope to include the VENTILATOR and its ACCESSORIES, where the characteristics of
those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the VENTILATOR, and thus,
not only the VENTILATOR itself;
— identification of ESSENTIAL PERFORMANCE for a VENTILATOR and its ACCESSORIES;
— modification of the obstruction of the expiratory limb (continuing AIRWAY PRESSURE) ALARM
CONDITION requirement;
and the following additions:
— tests for ventilation performance;
— tests for mechanical strength (via IEC 60601‐1‐11);
— new symbols;
© ISO 2015 – All rights reserved vii

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
— requirements for a VENTILATOR as a component of an ME SYSTEM;
— tests for ENCLOSURE integrity (water ingress via IEC 60601‐1‐11);
— tests for cleaning and disinfection PROCEDURES (via IEC 60601‐1‐11);
— consideration of contamination of the breathing gas delivered to the PATIENT from the gas
pathways.
ISO 80601 consists of the following parts, under the general title Medical electrical equipment:
— Part 2-12: Particular requirements for basic safety and essential performance of critical care
ventilators
— Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic
workstation
— Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas
monitors
— Part 2-56: Particular requirements for basic safety and essential performance of clinical
thermometers for body temperature measurement
— Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter
equipment for medical use
— Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving
equipment
— Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator
equipment
— Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea
breathing therapy equipment
— Part 2-72: Particular requirements for basic safety and essential performance of home healthcare
environment ventilators for ventilator-dependent patients
IEC 80601 consists of the following parts, under the general title Medical electrical equipment:
— Part 2-30: Particular requirements for the basic safety and essential performance of automated non-
invasive sphygmomanometers
— Part 2-35: Particular requirements for the basic safety and essential performance of heating devices
using blankets, pads and mattresses and intended for heating in medical use
— Part 2-58: Particular requirements for the basic safety and essential performance of lens removal
devices and vitrectomy devices for ophthalmic surgery
— Part 2-59: Particular requirements for the basic safety and essential performance of screening
thermographs for human febrile temperature screening
— Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
The ISO and IEC 80601 family of standards are also parts of the IEC 60601 family of standards.
viii © ISO 2015 – All rights reserved

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Introduction
This part of ISO 80601 specifies requirements for lung ventilators that are intended for use in the HOME
HEALTHCARE ENVIRONMENT for PATIENTS who are dependent for ventilation for their life support. These
VENTILATORS are frequently used in locations where the power driving the VENTILATOR is not reliable.
These VENTILATORS are often supervised by non‐healthcare personnel (LAY OPERATORS) with varying
levels of training. Lung ventilators complying with this standard can be used elsewhere (i.e. in
healthcare facilities).
In referring to the structure of this part of ISO 80601,
— “clause” means one of the 17 numbered divisions within the table of contents, inclusive of all
subdivisions (e.g. Clause 7 includes 7.1, 7.2, etc.), and
— “subclause” means a numbered subdivision of a clause (e.g. 201.7.1, 201.7.2 and 201.7.2.1 are all
subclauses of Clause 201.7).
References to clauses within this part of ISO 80601 are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular part of ISO 80601 are by number only.
In this part of ISO 80601, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this part of ISO 80601 conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this part of ISO 80601, the auxiliary verb
— “shall” means that compliance with a requirement or a test is mandatory for compliance with this
part of ISO 80601,
— “should” means that compliance with a requirement or a test is recommended but is not mandatory
for compliance with this part of ISO 80601, and
— “may” is used to describe a permissible way to achieve compliance with a requirement or test.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates
that there is guidance or rationale related to that item in Annex AA.
The attention of Member Bodies and National Committees is drawn to the fact that equipment
manufacturers and testing organizations might need a transitional period following publication of a
new, amended, or revised ISO or IEC publication in which to make products in accordance with the new
requirements and to equip them for conducting new or revised tests. It is the recommendation of the
committee that the content of this part of ISO 80601 not be adopted for mandatory implementation
nationally earlier than three years from the date of publication for equipment newly designed and not
earlier than five years from the date of publication for equipment already in production.
© ISO 2015 – All rights reserved ix

BS EN ISO 80601-2-72:2015
INTERNATIONAL STANDARD BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Medical electrical equipment — Part 2-72: Particular

requirements for basic safety and essential performance of
home healthcare environment ventilators for ventilator-
dependent patients
201.1 Scope, object, and related standards

IEC 60601‐1:2005+AMD1:2012, Clause 1 applies, except as follows:
201.1.1 *Scope
IEC 60601‐1:2005+AMD1:2012, 1.1 is replaced by:
This part of ISO 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a VENTILATOR in
combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT:
— intended for use in the HOME HEALTHCARE ENVIRONMENT;
— intended for use by a LAY OPERATOR;
— intended for use with PATIENTS who are dependent on mechanical ventilation for their life support.
NOTE 1 Such VENTILATORS can also be used for PATIENTS who are not dependent on ventilatory support.
NOTE 2 In the HOME HEALTHCARE ENVIRONMENT, the power driving the VENTILATOR is often not reliable.
NOTE 3 Such VENTILATORS can also be used in non‐critical care applications of professional health care facilities.
This part of ISO 80601 is also applicable to those ACCESSORIES intended by their MANUFACTURER to be
connected to a VENTILATOR BREATHING SYSTEM or to a VENTILATOR where the characteristics of those
ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR.
EXAMPLES Breathing tubes, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER,
external electrical power source, and DISTRIBUTED ALARM SYSTEM.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS

only, the title and content of that clause or subclause will say so. If that is not the case, the clause or
subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope
of this part of ISO 80601 are not covered by specific requirements in this part of ISO 80601 except in
IEC 60601‐1:2005+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 4 Additional information can be found in IEC 60601–1:2005+AMD1:2012, 4.2.
This part of ISO 80601 is not applicable to continuous positive airway pressure (CPAP) ME EQUIPMENT,
high‐frequency jet ventilators (HFJVs), and high‐frequency oscillatory ventilators (HFOVs)[35].
This part of ISO 80601 does not specify the requirements for cuirass and “iron‐lung” VENTILATORS.
This part of ISO 80601 does not specify the requirements for VENTILATORS or ACCESSORIES intended for
critical care applications, which are given in ISO 80601‐2‐12.
© ISO 2015 – All rights reserved 1

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
anaesthetic applications, which are given in ISO 80601‐2‐13.
emergency and transport which are given in ISO 10651‐3.
NOTE 5 In the future, ISO 10651‐3 is expected to be harmonized with IEC 60601‐1:2005, at which time it will
be replaced by ISO 80601‐2‐xx.
home‐care ventilatory support equipment (intended only to augment the ventilation of spontaneously
breathing PATIENTS), which are given in ISO 10651‐6.
NOTE 6 In the future, ISO 10651‐6 is expected to be harmonized with IEC 60601‐1:2005 and IEC 60601‐1‐
11:2015, at which time it will be replaced by ISO 80601‐2‐xx.
This part of ISO 80601 does not specify the requirements for obstructive sleep apnoea therapy
ME EQUIPMENT, which are given in ISO 80601‐2‐70.[16]
This part of ISO 80601 is a particular International Standard in the IEC 60601‐1 and ISO/IEC 80601
series of standards.
201.1.2 Object
The object of this part of ISO 80601 is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for a VENTILATOR, as defined in 201.3.217, and its ACCESSORIES.
NOTE ACCESSORIES are included because the combination of the VENTILATOR and the ACCESSORIES needs to be
adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL PERFORMANCE of a
VENTILATOR.
201.1.3 Collateral standards

IEC 60601‐1:2005+AMD1:2012, 1.3 applies with the following addition:
This part of ISO 80601 refers to those applicable collateral standards that are listed in
IEC 60601‐1:2005+AMD1:2012, Clause 2, as well as 201.2 of this part of ISO 80601.
IEC 60601‐1‐3:2008 does not apply.
201.1.4 Particular standards
In the IEC 60601 series, particular standards can modify, replace, or delete requirements contained in
the general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT
under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.
A requirement of a particular standard takes priority over IEC 60601‐1:2005+AMD1:2012 or the
collateral standards.
For brevity, IEC 60601‐1:2005+AMD1:2012 is referred to in this part of ISO 80601 as the general
standard. Collateral standards are referred to by their document number.
The numbering of clauses and subclauses of this part of ISO 80601 corresponds to those of the general
standard with the prefix “201” (e.g. 201.1 in this part of ISO 80601 addresses the content of Clause 1 of
the general standard) or applicable collateral standard with the prefix “2xx” where xx is the final digits
of the collateral standard document number (e.g. 202.4 addresses the content of IEC 60601‐1‐2,
Clause 4 collateral standard, 208.4 addresses the content of IEC 60601‐1‐8, Clause 4 collateral standard,
etc.). The changes to the text of the general standard are specified by the use of the following words:
2 © ISO 2015 – All rights reserved

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
— “Replacement” means that the clause or subclause of IEC 60601‐1:2005+AMD1:2012 or the

applicable collateral standard is replaced completely by the text of this part of ISO 80601.
— “Addition” means that the text of this particular standard is additional to the requirements of
IEC 60601‐1:2005+AMD1:2012 or the applicable collateral standard.
— “Amendment” means that the clause or subclause of IEC 60601‐1:2005+AMD1:2012 or the

applicable collateral standard is amended as indicated by the text of this part of ISO 80601.
Subclauses or figures that are additional to those of the general standard are numbered starting from
201.101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures that are additional to those of a collateral standard are numbered starting from
20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2, 203 for
IEC 60601‐1‐3, etc.
The term “this standard” is used to make reference to IEC 60601‐1:2005+AMD1:2012, any applicable
collateral standards, and this part of ISO 80601 taken together.
Where there is no corresponding clause or subclause in this part of ISO 80601, the clause or subclause
of IEC 60601‐1:2005+AMD1:2012 or the applicable collateral standard, although possibly not relevant,
applies without modification; where it is intended that any part of IEC 60601‐1:2005+AMD1:2012 or
the applicable collateral standard, although possibly relevant, is not to be applied, a statement to that
effect is given in this part of ISO 80601.
201.2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the bibliography beginning on page 81.

Replacement:
IEC 60601‐1‐2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
IEC 60601‐1‐6:2010 1 , Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
+Amendment 1:2013
IEC 60601‐1‐8:2006 2 , Medical electrical equipment — Part 1-8: General requirements for basic safety and
essential performance — Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems
+Amendment 1:2012
IEC 60601‐1‐11:2015, Medical electrical equipment – Part 1-11: General requirements for basic safety
and essential performance – Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
1 There exists a consolidated edition 3.1(2013) including IEC 60601‐1‐6:2010 and its Amendment 1:2013.
2 There exists a consolidated edition 2.1(2012) including IEC 60601‐1‐8:2006 and its Amendment 1:2012.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
IEC 61672‐1:2002, Electroacoustics — Sound level meters — Part 1: Specifications

Addition:
ISO 32:1977, Gas cylinders for medical use — Marking for identification of content
ISO 594‐1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594‐2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and
equipment
ISO 5356‐1:2004, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and
sockets
ISO 5359:2008, Low-pressure hose assemblies for use with medical gases
ISO 5367:2000, Breathing tubes intended for use with anaesthetic apparatus and ventilators
ISO 7000:2014, Graphical symbols for use on equipment — Registered symbols
ISO 7010:2011, Graphical symbols — Safety colours and safety signs — Registered safety signs
ISO 7396‐1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 8185:2007 3 , Respiratory tract humidifiers for medical use — Particular requirements for respiratory
humidification systems
ISO 8836:2007, Suction catheters for use in the respiratory tract
ISO 9360‐1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
ISO 9360‐2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for
humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having
minimum tidal volumes of 250 ml
ISO 11195:1995, Gas mixers for medical use — Stand-alone gas mixers
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 15223‐1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17664:2004, Sterilization of medical devices — Information to be provided by the manufacturer for
the processing of resterilizable medical devices
ISO 23328‐1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method
to assess filtration performance
3 To be replaced by ISO 80601‐2‐74.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
ISO 23328‐2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
ISO 80369‐1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1:
General requirements
ISO 80601‐2‐13:2011, Medical electrical equipment — Part 2-13: Particular requirements for basic safety
and essential performance of an anaesthetic workstation
ISO 80601‐2‐55:2011, Medical electrical equipment — Part 2-55: Particular requirements for the basic
safety and essential performance of respiratory gas monitors
ISO 17510:— 4 , Sleep apnoea breathing therapy masks and application accessories
IEC 60601‐1:2005 5 , Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
+Amendment 1:2012
IEC 62304:2006, Medical device software — Software life cycle processes
IEC 62366:2007 6 , Medical devices — Application of usability engineering to medical devices
EN 15986:2011, Symbol for use in the labelling of medical devices — Requirements for labelling of
medical devices containing phthalates
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7396‐1:2007, ISO 8185:2007,
ISO 9360‐1:2000, IEC 60601‐1:2005+AMD1:2012, IEC 60601‐1‐2:2014, IEC 60601‐1‐6:2010
+AMD1:2013, IEC 60601‐1‐8:2006+AMD1:2012, IEC 62304:2006, IEC 62366:2007+AMD1:2014,
ISO 4135:2001, and the following apply.
Addition:
201.3.201
AIRWAY PRESSURE
Paw
pressure at the PATIENT‐CONNECTION PORT
201.3.202
BREATHING SYSTEM FILTER
BSF
device intended to reduce transmission of particulates, including microorganisms, in breathing systems
[SOURCE: ISO 23328‐2:2002, 3.1]
201.3.203
DELIVERED VOLUME
Vdel
volume of gas delivered through a PATIENT‐CONNECTION PORT during a breath
Note 1 to entry: DELIVERED VOLUME is also referred to as tidal volume when all of the DELIVERED VOLUME enters the
PATIENT’S respiratory tract. This is frequently not the case when there is significant leakage around an uncuffed (as
in neonates) or otherwise unsealed tracheal tube or during non‐invasive ventilation.
[SOURCE: ISO 4135:2001, 3.4.2 modified — Replaced the ‘inspiratory phases’ with ‘a breath’ and added
note to entry.]
4 To be published.
5 There exists a consolidated edition 3.1(2012) including IEC 60601‐1:2005 and its Amendment 1:2012.
6 There exists a consolidated edition 2.1(2014) including IEC 62366:2007 and its Amendment 1:2014.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
201.3.204
EXHAUST PORT
port through which waste gas is discharged to the atmosphere or to an ANAESTHETIC GAS SCAVENGING
SYSTEM
[SOURCE: ISO 4135:2001, 4.2.1.6, modified—Deleted ‘excess and/or’.]

201.3.205
FLOW-DIRECTION-SENSITIVE COMPONENT
component or ACCESSORY through which gas flow has to be in one direction only for proper functioning or
PATIENT safety
[SOURCE: ISO 4135:2001, 3.1.7, modified — Added ‘or ACCESSORY’ and replaced ‘must’ with ‘has to’.]
201.3.206
FRESH GAS
respirable gas delivered to a VENTILATOR BREATHING SYSTEM
Note 1 to entry: FRESH GAS does not include the following:
— air drawn through the emergency intake port;
— air drawn through leaks in the VENTILATOR BREATHING SYSTEM;
— gas exhaled by the PATIENT.
[SOURCE: ISO 4135:2001, 3.1.8, modified — Added ‘VENTILATOR’ and note to entry.]
201.3.207
GAS INTAKE PORT
port through which gas is drawn for use by the PATIENT
[SOURCE: ISO 4135:2001, 3.2.11, modified — Replaced ‘a ventilator or by a patient’ with ‘for use by the
PATIENT’.]
201.3.208
GAS OUTPUT PORT
port through which gas is delivered at respiratory pressures through the inspiratory limb to the PATIENT‐
CONNECTION PORT
[SOURCE: ISO 4135:2001, 3.2.8, modified — Deleted ‘of a ventilator’ and replaced ‘through a tube’ with
‘through the inspiratory limb’.]
201.3.209
GAS RETURN PORT
port through which gas is returned at respiratory pressures via the expiratory limb from the PATIENT‐
CONNECTION PORT
[SOURCE: ISO 4135:2001, 3.2.9, modified — Deleted ‘of a ventilator’ and replaced ‘through a tube’ with
‘via the expiratory limb’.]
201.3.210
HIGH-PRESSURE INPUT PORT
input port to which gas is supplied at a pressure exceeding 100 kPa
[SOURCE: ISO 4135:2001, 3.2.10.1, modified — Replaced ‘may’ with ‘is’.]
201.3.211
MANUAL VENTILATION PORT
port to which a manual inflating device can be connected
[SOURCE: ISO 4135:2001, 3.2.12 modified — Deleted ‘of a ventilator’ and replaced ‘may’ with ‘can’.]

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ISO 80601-2-72:2015(E)
201.3.212
MAXIMUM LIMITED PRESSURE
PLIM max
highest AIRWAY PRESSURE during NORMAL USE or under SINGLE FAULT CONDITION
201.3.213
MONITORING EQUIPMENT
ME EQUIPMENT or part that continuously or continually measures and indicates the value of a variable to
the OPERATOR
201.3.214
PATIENT-CONNECTION PORT
port at the PATIENT end of a VENTILATOR BREATHING SYSTEM intended for connection to an airway device
EXAMPLES Tracheal tube, tracheostomy tube, face MASK, and supralaryngeal airway are all airway devices.
Note 1 to entry: The PATIENT‐CONNECTION PORT is the end of the VENTILATOR BREATHING SYSTEM proximal to the PATIENT.
[SOURCE: ISO 4135:2001, 4.2.1.2, modified — Added ‘VENTILATOR’ and note to entry and modernized the
examples.]
201.3.215
PEEP
POSITIVE END-EXPIRATORY PRESSURE
positive AIRWAY PRESSURE at the end of an expiratory phase
[SOURCE: ISO 4135:2001, 3.3.11]
201.3.216
PROTECTION DEVICE
part or function of ME EQUIPMENT that, without intervention by the OPERATOR, protects the PATIENT from
hazardous output due to incorrect delivery of energy or substances
201.3.217
VENTILATOR
VENTILATOR FOR VENTILATOR-DEPENDENT PATIENT
ME EQUIPMENT intended to augment or provide ventilation of the lungs of a PATIENT who is dependent on
this ventilation in the HOME HEALTHCARE ENVIRONMENT
Note 1 to entry: For the purposes of this part of ISO 80601, dependent means needed for the majority of the day
(e.g. an average need of more than 16 h of ventilation per day).
Note 2 to entry: A VENTILATOR FOR VENTILATOR‐DEPENDENT PATIENT is typically used without continuous healthcare
professional supervision.
Note 3 to entry: As this VENTILATOR is intended to be applied to PATIENTS who are VENTILATOR‐dependent, the
VENTILATOR is considered to be a LIFE‐SUPPORTING ME EQUIPMENT OR ME SYSTEM.
Note 4 to entry: A VENTILATOR complying with ISO 80601 may also be used in lower acuity settings in professional
healthcare facilities.
201.3.218
VENTILATOR BREATHING SYSTEM
VBS
inspiratory or expiratory pathways through which gas flows at respiratory pressures and bounded by the
port through which FRESH GAS enters, the PATIENT‐CONNECTION PORT, and the EXHAUST PORT
201.4 General requirements
201.4.3 ESSENTIAL PERFORMANCE
IEC 60601‐1:2005+AMD1:2012, 4.3 applies, except as follows:

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Additional subclause:
201.4.3.101 * Additional requirements for ESSENTIAL PERFORMANCE
Additional ESSENTIAL PERFORMANCE requirements are found in the subclauses listed in Table 201.101.
Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements
Requirement Subclause
Delivery of ventilation at the PATIENT‐CONNECTION PORT within the a
ALARM LIMITS set by the OPERATOR or
generation of an ALARM CONDITION

AIRWAY PRESSURE 201.12.4.102
continuing positive‐pressure 201.12.4.110
DELIVERED VOLUME 201.12.1.104
expired etCO2b, if provided 201.12.4.104
high AIRWAY PRESSURE 201.12.4.106
hypoventilation 201.12.4.109
INTERNAL ELECTRICAL POWER SOURCE nears depletion 211.8.4.101
high leakage 201.12.4.111
low expired volumec, if provided 201.12.4.103
obstruction 201.12.4.107
oxygen levelsd, if provided 201.12.4.101
a 202.8.1.101 indicates methods of evaluating delivery of ventilation as acceptance criteria following
specific tests required by ISO 80601 series.
b If expired volume monitoring is not provided or high leakage is not in use.
c If etCO2 monitoring or high leakage is not in use.
d If a control for the setting of the inspiratory oxygen concentration is provided.
201.4.6 * ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Amendment (add at end of 4.6 prior to the compliance check):
The gas pathways shall be subject to the requirements for APPLIED PARTS according to this subclause. The
VBS or its parts or ACCESSORIES that can come into contact with the PATIENT shall be subject to the
requirements for APPLIED PARTS according to this subclause.
201.4.10.2* SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
The characteristics of the SUPPLY MAINS specified in 4.10.2 of the general standard apply, except for the
following.
Replacement of the tenth dash as follows.
— For operation from 12 V d.c. SUPPLY MAINS
— the RATED range shall include at least 12,4 V to 15,1 V, and
— the ME EQUIPMENT shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during and following a
30 s dip to 10 V.
— for operation from 24 V d.c. SUPPLY MAINS

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
— the RATED range shall include at least 24,8 V to 30,3 V, and
— the ME EQUIPMENT shall maintain BASIC SAFETY and ESSENTIAL PERFORMANCE during and following a
30 s dip to 20 V.
— for operation from other d.c. SUPPLY MAINS
— a d.c. voltage (as measured by a moving coil meter or equivalent method) having a peak‐to‐
peak ripple not exceeding 10 % of the average value.
Additional subclauses:
201.4.11.101 * Additional requirements for pressurized gas input
201.4.11.101.1 Overpressure requirement
If the VENTILATOR is intended to be connected to a MEDICAL GAS PIPELINE SYSTEM complying with
ISO 7396‐1:2007, then it shall operate and meet the requirements of this part of ISO 80601 throughout
its RATED range of input pressure and shall not cause an unacceptable RISK under the SINGLE FAULT
CONDITION of 1 000 kPa.
NOTE 1 Internal pressure regulators can be needed to accommodate the SINGLE FAULT CONDITION of maximum
input pressure, as well as the RATED range of input pressure.
NOTE 2 Under the SINGLE FAULT CONDITION of overpressure, it is desirable for gas to continue to flow to the
VBS. Under this condition, the flowrate from the VENTILATOR is likely to be outside of its specification.
If the VENTILATOR has a maximum RATED input pressure in excess of 600 kPa, the VENTILATOR shall not
cause an unacceptable RISK under the SINGLE FAULT CONDITION of twice the maximum RATED input
pressure.
Check compliance by functional testing in NORMAL USE and under NORMAL CONDITION with the most adverse
operating settings, by functional testing in SINGLE FAULT CONDITION and inspection of the RISK MANAGEMENT
FILE.
201.4.11.101.2 Compatibility requirement

If the VENTILATOR is intended to be connected to a MEDICAL GAS PIPELINE SYSTEM complying with
ISO 7396‐1:2007, then
— the RATED range of input pressure shall cover the range specified in ISO 7396‐1:2007, and
— under NORMAL CONDITION,
1) the maximum 10 s average input flow required by the VENTILATOR for each gas shall not exceed
60 l/min at a pressure of 280 kPa, measured at the gas input port, and
2) the transient input flow shall not exceed 200 l/min averaged for 3 s
or
3) the ACCOMPANYING DOCUMENTS shall disclose the following:
i) the maximum 10 s average input flow required by the VENTILATOR for each gas at a
pressure of 280 kPa, measured at the gas input port;
ii) the maximum transient input flow averaged for 3 s required by the VENTILATOR for each gas
at a pressure of 280 kPa, measured at the gas input port;

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
iii) a warning to the effect that this VENTILATOR is a high‐flow device and should only be
connected to a pipeline installation designed using a diversity factor that allows for the
indicated high flow at a specified number of terminal outlets, in order to avoid exceeding
the pipeline design flow, thereby minimizing the RISK that the VENTILATOR interferes with
the operation of adjacent equipment.
Check compliance by functional testing in NORMAL USE and under NORMAL CONDITION with the most adverse
operating settings and by inspection of the ACCOMPANYING DOCUMENTS.
EXAMPLE The highest driving gas consumption, the highest FRESH GAS delivery, and, if provided, the highest
RATED gas consumption at any gas power supply output.
201.5 General requirements for testing of ME EQUIPMENT

IEC 60601‐1:2005+AMD1:2012, Clause 5 applies, except as follows.
Addition:
201.5.101 * Additional requirements for general requirements for testing of ME EQUIPMENT
201.5.101.1 VENTILATOR test conditions
For testing, the VENTILATOR shall be connected to gas supplies as specified for NORMAL USE, except that
industrial grade oxygen and air may be substituted for the equivalent medical gas, as appropriate,
unless otherwise stated. When using substitute gases, care should be taken to ensure that the test gases
are oil‐free and appropriately dry.
201.5.101.2 * Gas flowrate and leakage specifications
In this part of ISO 80601, requirements for the flowrate, volume, and leakage are expressed at standard
temperature and pressure, dry (STPD), except for those associated with the VBS, which are expressed at
body temperature and pressure, saturated (BTPS).
NOTE 1 For the purposes of this part of ISO 80601, STPD is 101,3 kPa at an operating temperature of 20 °C.
NOTE 2 For the purposes of this part of ISO 80601, BTPS is local atmospheric pressure and a relative humidity
of 100 % at an operating temperature of 37 °C.
Correct all test measurements to STPD or BTPS, as appropriate.

201.5.101.3 * VENTILATOR testing errors
For the purposes of this part of ISO 80601, declared tolerances shall include the measurement
uncertainty. The MANUFACTURER shall disclose the measurement uncertainty of each disclosed tolerance
in the technical description.
Check compliance by inspection of the instructions for use and the technical description.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS
IEC 60601‐1:2005, Clause 6 applies.
201.7 ME EQUIPMENT identification, marking, and documents

201.7.2.3 * Consult ACCOMPANYING DOCUMENTS
IEC 60601‐1:2005+AMD1:2012, 7.2.3 applies, except as follows.
Replacement:
The VENTILATOR shall be marked with the safety sign for the mandatory action: “follow instructions for
use”, ISO 7010‐M002 (see IEC 60601‐1:2005+AMD1:2012, Table D.2, Number 10).

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ISO 80601-2-72:2015(E)
201.7.2.4.101 Additional requirements for ACCESSORIES

ACCESSORIES supplied separately shall fulfil the requirements of 201.7.2.101, 201.7.2.13.101, and
201.7.2.17.101 and shall be marked with an indication of any limitations or adverse effects of the
ACCESSORY on the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR, if applicable. If marking the
ACCESSORY is not practicable, this information may be placed in the instructions for use.
NOTE The MANUFACTURER of the ACCESSORY can be the VENTILATOR MANUFACTURER or another entity (“third‐party
manufacturer”, healthcare provider or durable medical equipment provider) and all these entities are expected to
ensure compliance with this requirement. Additional requirements are found in 201.102.
Check compliance by inspection and inspection of the RISK MANAGEMENT FILE for any limitations or adverse
effects of the ACCESSORY.
201.7.2.13.101 Additional requirements for physiological effects
Any natural rubber latex‐containing components in the gas pathways or ACCESSORIES shall be marked as
containing latex. Such marking shall be CLEARLY LEGIBLE. Symbol 5.4.5 from ISO 15223‐1:2012
(Table 201.D.1.101, symbol 4) may be used. The instructions for use shall disclose any natural rubber
latex‐containing components.
Check compliance by inspection.
201.7.2.17.101 Additional requirements for protective packaging
The marking on packages shall be CLEARLY LEGIBLE and shall include the following:
a) description of the contents;
b) identification reference to the batch, type, or serial number or symbols 5.1.5, 5.1.6, or 5.1.7 from
ISO 15223‐1:2012 (Table 201.D.1.101, symbol 1, symbol 2, or symbol 3);
c) for packages containing natural rubber latex, the word “LATEX” or symbol 5.4.5 from
ISO 15223‐1:2012 (Table 201.D.1.101, symbol 4).
For a specific MODEL OR TYPE REFERENCE, the indication of single‐use shall be consistent for the MODEL OR
TYPE REFERENCE.

201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts
The marking of ME EQUIPMENT, parts, or ACCESSORIES shall be CLEARLY LEGIBLE and shall include the
following:
a) any special storage and/or handling instructions;
b) any particular warnings and/or precautions relevant to the immediate operation of the VENTILATOR.
If applicable, marking of OPERATOR‐accessible ME EQUIPMENT parts or ACCESSORIES shall be CLEARLY LEGIBLE

and shall include the following:
c) for any gas‐specific inputs or outlets,
— the gas name or chemical symbol in accordance with ISO 5359:2008,
— gas‐specific colour‐coding in accordance with ISO 32:1977, if colour coding is used;
EXAMPLE 1 For flow controls, flexible hoses, gas cylinders.

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NOTE In some countries, other colour coding is used.
d) an arrow indicating the direction of the flow for FLOW‐DIRECTION‐SENSITIVE COMPONENTS that are
OPERATOR‐removable without the use of a TOOL;
e) a warning not to obstruct the GAS INTAKE PORT.
EXAMPLE 2 WARNING: Gas Intake – Do not obstruct.

201.7.4.2 Control devices
Amendment (add after the second dash):
The marking of the trigger sensitivity control shall be such that the minimum (least PATIENT effort) and
the maximum (greatest PATIENT effort) trigger sensitivity settings are self‐evident to the OPERATOR. The
marking, if numeric, shall not only be numeric.
201.7.4.3 * Units of measurement
Amendment (add to the bottom as a new row in Table 1):
All gas volume, flow, and leakage specifications shall be expressed at standard temperature and
pressure, dry (STPD) except those associated with the VBS which shall be expressed at body
temperature and pressure, saturated (BTPS) absolute VBS pressure.
NOTE 1 For the purposes of this part of ISO 80601, STPD is 101,3 kPa at an operating temperature of 20 °C.
NOTE 2 For the purposes of this part of ISO 80601, BTPS is local atmospheric pressure and a relative humidity
of 100 % at an operating temperature of 37 °C.
The unit of AIRWAY PRESSURE measurement shall be capable of being configured to be expressed in hPa.
201.7.9.1 Additional general requirements
Amendment (replace the first dash with):
— Name or trade name and address of the following:
— the MANUFACTURER; and
— where the MANUFACTURER does not have an address within the locale, an authorized
representative within the locale,
to which the RESPONSIBLE ORGANIZATION can refer;
201.7.9.2 Instructions for use

201.7.9.2.1.101 Additional general requirements
Separate instructions for use shall be provided for the following:
— LAY OPERATOR;

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— supervising clinician or the healthcare professional OPERATOR.
The MANUFACTURER may choose in which instructions for use to place the information required by this
part of ISO 80601 unless otherwise indicated in this part of ISO 80601 based on RISK MANAGEMENT and
USABILITY considerations.
The supervising clinician or the healthcare professional OPERATOR instructions for use shall include the
information contained in the LAY OPERATOR instructions for use.
Check compliance by inspection of the instructions for use, the RISK MANAGEMENT FILE, and USABILITY
ENGINEERING FILE.

The instructions for use shall include the following:
a) if the VENTILATOR, its parts, or ACCESSORIES are intended for single‐use, information on known
characteristics and technical factors known to the MANUFACTURER that could pose a RISK if the
VENTILATOR, its parts, or ACCESSORIES were reused;
b) if the VENTILATOR, its parts, or ACCESSORIES are intended for single‐use, information regarding the
intended duration of use.

201.7.9.2.2.101 * Additional requirements for warnings and safety notices
The instructions for use shall include the following:
a) warning statement to the effect of “WARNING: To prevent death or serious injury, monitor the
patient and the ventilator regularly in order to determine the need to provide emergency
ventilation when an alarm sounds or the ventilator malfunctions.”
b) warning statement to the effect of “WARNING: Do not cover the ventilator or place in a position that
affects proper operation”, including applicable examples.
EXAMPLE 1 WARNING: Do not position next to a curtain that blocks the flow of cooling air, thereby
causing the ME EQUIPMENT to overheat.
EXAMPLE 2 WARNING: Do not block the GAS INTAKE PORT or EMERGENCY INTAKE PORT, thereby interfering
with PATIENT ventilation.
c) warning statement to the effect of “WARNING: Always have immediate access to an alternative
means of ventilation, which is ready for use, to avoid patient death or serious injury.”
EXAMPLE 3 Failure to have an alternative means of ventilation such as a second VENTILATOR of the same
type or a self‐inflating, manually powered resuscitator (as specified in ISO 10651‐4) with MASK can result in
PATIENT death if the VENTILATOR fails.
d) * a warning statement to the effect of “WARNING: Do not add any attachments or accessories to the
ventilator that are not listed in the instruction for use as the ventilator might not function
correctly.”
e) * if the instructions for use include a VBS configuration with a BSF exposed to the humidity from
nebulisation or humidification, a warning statement to the effect of “WARNING: When using
nebulisation or humidification, the breathing system filter will require more frequent replacement
to prevent increased resistance or blockage.”

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f) warning statement to the effect of “WARNING: Do not use the ventilator at an altitude above (insert
maximum RATED altitude) or outside a temperature of [insert RATED temperature range]. Using the
ventilator outside of this temperature range or above this altitude can affect the ventilator
performance which consequently can result in patient death.”
g) * warning statement to the effect of “WARNING: Do not connect the ventilator to the battery of a
battery‐powered wheelchair unless the connection is listed in the instruction for use of the
ventilator or wheelchair as this can affect the ventilator performance which can consequently
result in patient death.”
h) warning statement to the effect of “WARNING: When using the ventilator in a carrying case, only use
a carrying case that is listed in the instructions for use to prevent adverse ventilator performance
which can consequently result in patient death.”
i) warning statement to the effect of “WARNING: To reduce the likelihood of disconnection and to
prevent adverse ventilator performance, use only accessories compatible with the ventilator.
Compatibility is determined by reviewing the instructions for use of either the ventilator or the
accessories”.
j) if applicable, a warning statement to the effect of “WARNING: The ventilator accuracy can be
adversely affected by the gas added by the use of a pneumatic nebuliser.”
k) if applicable, a warning statement to the effect of “WARNING: Unintentional leaks cause indicated
volume and expired CO2 values to differ from actual patient values.”
Check compliance by inspection of the instructions for use.

201.7.9.2.8.101 * Additional requirements for start-up PROCEDURE
NOTE 1 For the purposes of this part of ISO 80601, a start‐up PROCEDURE is a pre‐use functional test that is used
to determine whether the VENTILATOR is ready for use.
The instructions for use for the LAY OPERATOR shall disclose a method by which the following can be
functionally tested to determine if they are operating correctly:
— the assembled breathing tubes and related ACCESSORIES;
— switchover to and operation from the INTERNAL ELECTRICAL POWER SUPPLY;
— all ALARM SIGNALS, including the ALARM SIGNALS from DISTRIBUTED ALARM SYSTEMS,
Portions of these test methods can be performed automatically by the VENTILATOR or can require
OPERATOR action.
EXAMPLE 1 Combination of the power‐on self‐test routines and OPERATOR actions that functionally check the
ALARM SIGNALS.
The specifications of any required ACCESSORIES or test equipment needed to perform these tests shall be
disclosed in the instructions for use for the LAY OPERATOR.
EXAMPLE 2 Volume, resistance, and compliance of the test lung necessary to perform the tests.
NOTE 2 Additional requirements are also found in 201.15.102.
The instructions for use for the supervising clinician or the healthcare professional OPERATOR shall
disclose a method by which all functions and settings necessary for NORMAL USE and can be functionally

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tested to determine if they are operating correctly. Portions of this test method can be performed
automatically by the VENTILATOR or can require OPERATOR action.
201.7.9.2.9.101 * Additional requirements for operating instructions
201.7.9.2.9.101.1 * LAY OPERATOR operating instructions
The instructions for use intended for the LAY OPERATOR shall include the following:
a) the conditions under which the VENTILATOR maintains the accuracy of controlled and displayed
variables as disclosed in the instructions for use;
EXAMPLE 1 Acceptable range of water level in a HUMIDIFIER.
EXAMPLE 2 Interval of calibration of a flow sensor.
b) an explanation of the meaning of the IP classification marked on the ME EQUIPMENT;
c) an indication as to whether the VENTILATOR is intended for non‐invasive ventilation;
EXAMPLE 3 MASK ventilation.
d) * a description of how at least the following ALARM CONDITIONS can be tested:
— high leakage;
— INTERNAL ELECTRICAL POWER SOURCE nears depletion;
— low AIRWAY PRESSURE;
— low inspiratory pressure;
— obstruction;
— power failure of external mains;
— power failure of external DC power
e) a description of how the following ALARM CONDITIONS, if provided, can be tested:
— low expired volume;
— oxygen levels
f) a description of a means to determine the operation time of the INTERNAL ELECTRICAL POWER SOURCE;
g) a description of how to connect and test the connection of a DISTRIBUTED ALARM SYSTEM.

201.7.9.2.9.101.2 * Supervising clinician operating instructions
The instructions for use intended for the supervising clinician or the healthcare professional OPERATOR
shall include a detailed description of the function of all ventilation modes provided by the VENTILATOR,
including but not limited to, the following items:
a) working principle of each of the VENTILATOR’S ventilation modes including waveforms;

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b) methods for controlling the cycling;
c) parameter settings;
d) range of parameter settings;
e) any limitation of parameter settings;
f) * a description of how at least the following ALARM CONDITIONS, if included, can be tested:
— continuing positive‐pressure;
— DELIVERED VOLUME;
— high AIRWAY PRESSURE;
— high expiratory volume;
— hypoventilation; and
— low expiratory volume.
The instructions for use intended for the supervising clinician or the healthcare professional OPERATOR
shall include
g) the RATED range of the following characteristics of the assembled OPERATOR‐detachable parts of the
VBS, over which the accuracies of set and monitored volumes and pressures are maintained:
— inspiratory gas pathway resistance;
— expiratory gas pathway resistance;
— compliance.
These specifications may be presented in ranges. The accuracies of set and monitored volumes may
be presented as a function of these characteristics.
NOTE Compliance and resistance can be nonlinear. These characteristics might need to be specified over a
range (e.g. at 15 l/min, 30 l/min, 60 l/min, maximum flowrate, or the maximum pressure).
If applicable, instructions for use intended for the supervising clinician or the healthcare professional
OPERATOR shall disclose
h) the essential technical characteristics of each recommended BREATHING SYSTEM FILTER, and
EXAMPLES Dead space and resistance.
i) a statement as to whether any portion of the gas supplied to a HIGH‐PRESSURE INPUT PORT is supplied
to the PATIENT.

201.7.9.2.12 Cleaning, disinfection, and sterilization
IEC 60601‐1:2005+AMD1:2012, 7.9.2.12 applies, except as follows.
Amendment: (add after NORMAL USE)

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and SINGLE FAULT CONDITION

Amendment: (add after bulleted list)
The instructions for use shall identify any portions of the gas pathways through the VENTILATOR that can
become contaminated with body fluids or expired gases during both NORMAL CONDITION and SINGLE FAULT
CONDITION.
201.7.9.2.13.101 Additional requirements for maintenance

The instructions for use shall disclose the following:
a) a description of periodic visual safety inspections that should be performed by the OPERATOR;
b) the INTERNAL ELECTRICAL POWER SOURCE care and maintenance PROCEDURES, including instructions for
recharging and replacement.

201.7.9.2.14.101 * Additional requirements for ACCESSORIES, supplementary equipment, used
material
If applicable, the instructions for use shall disclose the following:
a) any restrictions on the positioning of components within the VENTILATOR BREATHING SYSTEM;
EXAMPLE Where such components are FLOW‐DIRECTION‐SENSITIVE COMPONENTS.
b) any adverse effect of any recommended ACCESSORY on the ESSENTIAL PERFORMANCE or BASIC SAFETY of
the VENTILATOR.
Check compliance by inspection of the instructions for use and inspection of the RISK MANAGEMENT FILE for
any adverse effect of any recommended ACCESSORY.
201.7.9.3.1.101 * Additional general requirements
The technical description shall disclose the following:
a) summary description of the filtering and/or smoothing techniques for all measured and/or
computed variables that are displayed or used for control;
b) interdependence of control functions;
c) pneumatic diagram of the VENTILATOR, including a diagram for OPERATOR‐detachable parts of the
VENTILATOR BREATHING SYSTEM either supplied or recommended in the instructions for use;
d) summary description of the means of initiating and terminating the inspiratory phase while the
ventilator is operating in each of its ventilatory modes;
e) means by which the continuing pressure ALARM CONDITION is detected and a summary description of
the detection algorithm;
f) statement to the effect that the responsible organization needs to ensure the compatibility of the
ventilator and all of the parts and accessories intended to be used to connect to the patient prior to
use.
Check compliance by inspection of the technical description.

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201.7.9.3.101 Additional requirements for the technical description

The technical description shall disclose a description of a method for checking the function of the ALARM
SYSTEM for each of the ALARM CONDITIONS specified in this part of ISO 80601, if not performed
automatically during start‐up. The technical description shall disclose which checks are performed
automatically.
Check compliance by inspection of the technical description.
201.8 Protection against electrical HAZARDS from ME EQUIPMENT
IEC 60601‐1:2005+AMD1:2012, Clause 8 applies.
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS
201.9.4.3.101 Additional requirements for instability from unwanted lateral movement
A TRANSIT‐OPERABLE VENTILATOR shall include a means by which the VENTILATOR can be easily
immobilized without the use of a TOOL to prevent unwanted movement during transport while in use.
EXAMPLES Means to attach during transport in a personal vehicle, in an ambulance, or on a wheelchair.
Compliance is checked by functional testing.

201.9.4.4 Grips and other handling devices
Replace list item b) with the following:
b) The VENTILATOR shall have a carrying handle suitably placed to enable the VENTILATOR to be carried
by one hand.
Compliance is checked by carrying.

201.9.6.2.1.101 Additional requirements for audible acoustic energy
The A‐weighted sound pressure level emitted by the VENTILATOR shall be measured in accordance with
ISO 4871:1996 and ISO 3744:2010 using engineering method grade 2 and disclosed in the instructions
for use. The A‐weighted sound power level shall be calculated according to ISO 3744:2010, 8.1 and
disclosed in the instructions for use.
Check compliance with the following test:
a) Place the VENTILATOR on the sound-reflecting plane and attach the least favourable VBS from those
indicated in the instructions for use.
NOTE The least favourable VBS configuration can vary by mode, breath type, and flow pattern, as
applicable.
b) If a HUMIDIFIER is provided with the VENTILATOR, include the HUMIDIFIER in the test and fill to the least
favourable level.
c) Configure the test lung with the compliance and resistance components whose values are indicated in
Table 201.102.
— Acoustically isolate the test lung by a suitable means so that any noise caused by the test lung
does not interfere with the sound measurement of the VENTILATOR.

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— Connect the PATIENT-CONNECTION PORT to the test lung.
Table 201.102 — Test conditions for acoustic tests

Adjustable parameter Test condition
For a VENTILATOR intended to provide DELIVERED VOLUME
Vdel ≥ 300 ml 300 ml ≥ Vdel ≥ 50 ml Vdel ≤ 50 ml
DELIVERED VOLUME, Vdela 500 ml 150 ml 30 ml
Ventilatory frequency, f 10 min‐1 20 min‐1 30 min‐1
I:E ratio 1:2 1:2 1:2
PEEP 5 hPa 5 hPa 5 hPa
Resistance, Rb[30][42][45] 5 hPa(l/s)‐1 ± 10 % 20 hPa(l/s)‐1 ± 10 % 50 hPa(l/s)‐1 ± 10 %
Isothermal Compliance, Cb 50 ml (hPa)‐1 ± 5 % 20 ml (hPa)‐1 ± 5 % 1 ml (hPa)‐1 ± 5 %
a Vdel is measured by means of a pressure sensor on the test lung, where VT = C × Pmax.
b The accuracy for C and R applies over the ranges of the measured parameters.
d) Set the VENTILATOR to the least favourable mode, breath type, and flow pattern, as applicable, that
generates ventilation as indicated in Table 201.102.
NOTE The least favourable mode, breath type, and flow pattern can vary by VBS configuration.
e) Using the microphone of the sound level meter complying with the requirements of type 1 instruments
specified in IEC 61672-1:2002, measure the sound pressure levels at ten positions in a hemisphere with
a radius from the geometric centre of the VENTILATOR as specified in ISO 3744:2010, 7.2.
f) Calculate the A-weighted sound pressure level averaged over the measurement surface according to
ISO 3744:2010, 8.1.
g) Calculate the A-weighted sound power level according to ISO 3744:2010, 8.6.
h) Confirm that the A-weighted background level of extraneous noise is at least 6 dB below that measured
during the test.
i) Take measurements using the frequency-weighting characteristic A and the time-weighting

characteristic F on the sound level meter in a free field over a reflecting plane as specified in
ISO 3744:2010. Average the values in accordance with ISO 3744:2010, 8.1.
j) Ensure that the measured sound pressure level is less than that disclosed in the instructions for use.
201.10 Protection against unwanted and excessive radiation HAZARDS

201.11 Protection against excessive temperatures and other HAZARDS
201.11.1.2.2 * APPLIED PARTS not intended to supply heat to a PATIENT
Amendment (add between the existing paragraphs):
Over the RATED flowrate range and at the maximum RATED operating temperature, the temperature of
the gas delivered by the VENTILATOR, both with and without a HUMIDIFIER, shall not exceed an energy

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equivalent to 43 °C and 100 % relative humidity (a specific enthalpy not to exceed 197 kJ/m3 dry air)
when averaged over 120 s.
Table 201.103 contains examples of combinations of temperature and relative humidity with such a
specific enthalpy.
Table 201.103 — Examples of permissible combinations of temperature and relative humidity

Temperature Relative humidity
°C %
43 100
44 95
45 90
48 76
50 71
201.11.6.4 Leakage
Amendment (add after existing text):
The MANUFACTURER of a VENTILATOR, VBS, its parts, and ACCESSORIES shall address in the RISK MANAGEMENT
PROCESS the RISKS associated with the leaching or leaking of substances into the gas pathway. Special
attention shall be given to substances which are carcinogenic, mutagenic, or toxic to reproduction.
The ACCESSIBLE PARTS and gas pathways of a VENTILATOR, VBS, its parts, or ACCESSORIES that contain
phthalates which are classified as carcinogenic, mutagenic, or toxic to reproduction shall be marked on
the device itself or on the packaging that it contains phthalates. If the INTENDED USE of a VENTILATOR, VBS,
its parts, or ACCESSORIES includes treatment of children or treatment of pregnant or nursing women, a
specific justification for the use of these phthalates shall be included in the RISK MANAGEMENT FILE. The
instructions for use of a VENTILATOR, VBS, its parts, or ACCESSORIES that contain such phthalates shall
contain information on RESIDUAL RISKS for these PATIENT groups and, if applicable, on appropriate
precautionary measures.
Check compliance by inspection of the instructions for use and inspection of the RISK MANAGEMENT FILE for
identification of the presence of substances which are carcinogenic, mutagenic, or toxic to reproduction
and justification for their use.
201.11.6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM
Amendment (add additional requirement as new first paragraph):
Gas pathways through the VENTILATOR and its ACCESSORIES that can become contaminated with body
fluids or expired gases during NORMAL CONDITION or SINGLE FAULT CONDITION shall be designed to allow for
cleaning and disinfection or cleaning and sterilization (additional requirements are found in
IEC 60601‐1:2005, 11.6.7 and IEC 60601‐1:2005/AMD1:2012 and IEC 60601‐1‐11:2015, Clause 8).
Dismantling or parts replacement may be performed.
Amendment (add additional requirement and replace the compliance test):
VENTILATOR enclosures shall be designed to allow for surface cleaning and disinfection to reduce to
acceptable levels the RISK of infection of OPERATORS, bystanders, or the PATIENT.
Instructions for processing and reprocessing the VENTILATOR and its ACCESSORIES shall comply with
ISO 17664:2004 and ISO 14937:2009 and shall be disclosed in the instructions for use.
NOTE 1 ISO 14159 provides guidance for the design of enclosures.

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Check compliance by inspection of the RISK MANAGEMENT FILE. When compliance with this part of ISO 80601
could be affected by the cleaning or the disinfecting of the VENTILATOR or its parts or ACCESSORIES, clean and
disinfect them 10 times in accordance with the methods indicated in the instruction for use, including any
cooling or drying period. After these PROCEDURES, ensure that BASIC SAFETY and ESSENTIAL PERFORMANCE are
maintained. Confirm that the MANUFACTURER has evaluated the effects of multiple PROCESS cycles and the
effectiveness of those cycles.
NOTE 2 Additional information regarding the order of test is found in 211.10.1.1.
201.11.6.7 Sterilization of ME EQUIPMENT or ME SYSTEM

Amendment (add note before compliance test):
NOTE Additional requirements are found in IEC 60601–1:2005 and IEC 60601–1:2005/AMD1:2012, 11.6.6
and IEC 60601–1‐11:2015, Clause 8.
201.11.8 Interruption of the power supply/SUPPLY MAINS to ME EQUIPMENT

201.11.8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT
The VENTILATOR shall have a means of connection to an alternative SUPPLY MAINS. The instructions for use
shall include the following:
a) description of the means of connection;
b) RATED voltage range;
c) NOMINAL voltage range;
d) maximum current required.
A means of connection to an automotive vehicle power source should be provided.

EXAMPLES A 12 V d.c., 100 W connector, or other MAINS CONNECTOR.
Compliance is checked by inspection and inspection of the instructions for use.

201.12 * Accuracy of controls and instruments and protection against hazardous outputs
201.12.1 Accuracy of controls and instruments
Amendment (add after existing sentence):
The controls and indicators of a VENTILATOR shall be CLEARLY LEGIBLE under the conditions specified in
IEC 60601‐1:2005+AMD1:2012, 7.1.2, but with the subtended angle increased from ‘30°’ to ‘45°’ and
the light level extended from the range of ‘100 lx to 1 500 lx’ to the range of ‘1 lx to 10 000 lx’.
The VENTILATOR may provide means to reduce the visibility of its controls and indicators either
automatically or by the OPERATOR action. If provided, the VENTILATOR shall automatically resume normal
visibility during an ALARM CONDITION.
Check compliance by functional testing and application of the tests of IEC 60601-1:2005+AMD1:2012,
7.1.2.

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201.12.1.101 Breath types

A VENTILATOR shall be equipped with at least a volume‐controlled or pressure‐controlled breath type.
201.12.1.102 Volume-controlled breath type
If a volume‐controlled breath type is provided, then with a volume‐controlled breath type selected and
the VENTILATOR operating in NORMAL CONDITION, the accuracy as determined for the test settings and
conditions specified in this part of ISO 80601 shall be disclosed in the instructions for use, as the
maximum bias error and maximum linearity error.
EXAMPLE ±(5 ml + 10 % of the set volume).
This disclosure shall include at least the following:

— maximum error of the DELIVERED VOLUME in relation to the set value;
— maximum error of the PEEP in relation to the set value;
— if provided with a control for the setting of the inspiratory oxygen concentration, the maximum
error of the inspiratory oxygen concentration (FiO2) at the PATIENT‐CONNECTION PORT in relation to
the set value.
All of the errors may be separately reported for the following ranges of intended DELIVERED VOLUME:
— Vdel ≥ 300 ml;
— 300 ml ≥ Vdel ≥ 50 ml;
— Vdel ≤ 50 ml.
The accuracy of the performance of the VENTILATOR shall be either of the following:
— determined for each VBS configuration indicated in the instructions for use;
— determined for the worst‐case VBS configurations indicated in the instructions for use.
NOTE 1 The worst‐case VBS configuration can be different for each error or NOMINAL DELIVERED VOLUME.
If worst‐case VBS configurations are used, the rationale for their selection shall be documented in the
RISK MANAGEMENT FILE.
Check compliance by inspection of the RISK MANAGEMENT FILE for the rationale, if applicable, and with the
following tests:
NOTE 2 In some cases, the following tests can be carried out simultaneously.
a) DELIVERED VOLUME and end-expiratory pressure errors
1) Set up the VENTILATOR as shown in Figure 201.101.
2) If applicable, determine or input the VBS compliance required for compliance correction as
indicated in the instructions for use and activate this correction. If a HUMIDIFIER is used, fill the
HUMIDIFIER to the maximum water level prior to determining the VBS compliance.
3) Utilize the test parameters and settings of the first applicable row (selected by intended DELIVERED
VOLUME) of Table 201.104. Wait for steady-state conditions to be achieved.

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NOTE 3 Intentionally, for some of these tests (i.e. those utilizing a VBS with a large compliance and a high
resistance), the end‐expiratory flow will not reach zero.
4) Determine the DELIVERED VOLUME, for example, by integration of the flow signal provided by a
calibrated flow sensor located at the PATIENT-CONNECTION PORT or by the product of the test lung
compliance and the measured change of lung pressure compensated, if necessary, for temperature
effects due to fast compression of the gas.
NOTE 4 Additional information on the construction of an isothermal test lung is found in Reference [34].
5) Compare the result with the volume setting for the test. Confirm that the accuracy is within the
tolerance indicated in the instructions for use.
6) Determine the accuracy of the DELIVERED VOLUME MONITORING EQUIPMENT by comparing its reading
to the DELIVERED VOLUME determined in 4). Refer to 201.12.1.104.
7) Determine the PEEP as the average of the AIRWAY PRESSURE measurements over the last 50 ms of the
expiratory phase.
8) Compare the result with the PEEP setting for the test. Confirm that the resulting difference is
within the tolerance indicated in the instructions for use.
9) Repeat 3) to 8) for 30 consecutive breaths.
10) Repeat 3) to 9) for each applicable row (selected by intended DELIVERED VOLUME) of Table 201.104.
11) If a HUMIDIFIER is included in the VBS, repeat the DELIVERED VOLUME tests with the minimum
HUMIDIFIER water level without re-determining the VBS compliance.
12) Unless it can be demonstrated that the worst-case flow pattern (e.g. constant flow, decelerating
flow) has been selected for the tests, repeat 2) to 11) for each flow pattern available on the
VENTILATOR.
13) If the VENTILATOR permits operation without compliance correction, repeat 2) to 12) without
compliance correction.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Key
1 VENTILATOR under test
2 pressure sensor
3 flow sensor, with a 10 % to 90 % rise time of no greater than 10 ms
4 oxygen sensor, if applicable
5 data acquisition system, with minimum sample rate of 200 samples/s
6 temperature sensor
7 test lung resistance (Rlung)
8 pressure sensor, with a 10 % to 90 % rise time of no greater than 10 ms
9 test lung compliance (Clung)
10 test lung
11 artificial leakage (pressure‐controlled breath type only)
NOTE The oxygen sensor may be placed in the VBS.
Figure 201.101 — Typical test setup for volume-control and pressure-control breath type
accuracy
Table 201.104 — Volume-controlled breath TYPE TEST settings

Test Test lung parameters VENTILATOR settings
number
Compliance Linear[30][42][45] Volume Ventilatory INSPIRATORY FiO2a PEEP
(ml(hPa)‐1) resistance (ml) frequency TIME (%) (hPa)
(hPa(l/s)‐1) (breaths/min) (s)
± 10 %
± 10 %
1 50 5 500 20 1 28 5
2 50 20 500 20 1 35 10
3 20 5 500 20 1 35 5
4 20 20 500 20 1 28 10

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Table 201.104 (continued)

Test Test lung parameters VENTILATOR settings
number
Compliance Linear[30][42][45] Volume Ventilatory INSPIRATORY FiO2a PEEP
(ml(hPa)‐1) resistance (ml) frequency TIME (%) (hPa)
(hPa(l/s)‐1) (breaths/min) (s)
± 10 %
± 10 %
5 20 20 300 20 1 28 5
6 20 50 300 20 1 35 10
7 10 50 300 20 1 28 10
8 10 20 200 20 1 35 5
9 3 20 50 30 0,6 28 5
10 3 50 50 30 0,6 28 10
11 3 200 50 30 0,6 35 5
a If the VENTILATOR is not provided with a control for the setting of the inspiratory oxygen concentration, room
air is used.
b) FiO2 error
14) If provided with a control for the setting of the inspiratory oxygen concentration, the accuracy of
the inspiratory O2 concentration of the gas delivered is assessed by placing the sensor of an O2
concentration-measuring device at the PATIENT-CONNECTION PORT or inside the test lung. If the
sensor is located at the PATIENT-CONNECTION PORT, the value of the concentration is the flow-
weighted average concentration during the inspiratory phase.
15) Compare the measured O2 concentration with the FiO2 setting. Confirm that the difference is
NOTE 5 If the sensor is located inside the test lung, care should be taken to allow sufficient time for the gas
mixture in the test lung to reach a stable concentration.
NOTE 6 If the sensor is located in the tubing system, care should be taken to ensure that the measuring
device has a sufficiently fast response to permit determination of the flow‐weighted average concentration
during the inspiratory phase.
NOTE 7 If the O2 concentration‐measuring device has pressure dependencies, compensate for these
dependencies.
16) Obtain the FiO2 error by comparing the FiO2 setting to the measured value for each test in a)
above.
17) Confirm that each result is within the tolerance indicated in the instructions for use.
201.12.1.103 Pressure-controlled breath type

If a pressure‐controlled breath type is provided, then with a pressure‐controlled breath type selected
and the VENTILATOR operating in NORMAL CONDITION, the accuracy as determined for the test settings and
conditions specified in this part of ISO 80601 shall be disclosed in the instructions for use as the
maximum bias error and maximum linearity error.
EXAMPLE ±(3,0 hPa + 5 % of the set pressure).
This disclosure shall include at least the following:

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
— the maximum error of the AIRWAY PRESSURE (Paw) at the end of the inspiratory phase in relation to
the set value;
— the maximum error of the AIRWAY PRESSURE (Paw) at the end of the inspiratory phase in relation to
the set value under leak condition;
— the maximum error of PEEP in relation to the set value;
— if provided with a control for the setting of the inspiratory oxygen concentration, the maximum
error of the inspiratory oxygen concentration (FiO2) at the PATIENT‐CONNECTION PORT in relation to
the set value.
All of the errors may be separately reported for the following ranges of intended DELIVERED VOLUME:
— Vdel ≥ 300 ml;
— 300 ml ≥ Vdel ≥ 50 ml;
— Vdel ≤ 50 ml.
The accuracy of the performance of the VENTILATOR shall be either of the following:
— determined for each VBS configuration indicated in the instructions for use;
— determined for the worst‐case VBS configuration indicated in the instructions for use.
NOTE 1 The worst‐case VBS configuration can be different for each error or each NOMINAL DELIVERED VOLUME
range.
If worst‐case VBS configurations are used, the rationale for their selection shall be documented in the
RISK MANAGEMENT FILE.
Check compliance by inspection of the RISK MANAGEMENT FILE for the rationale, if applicable, and with the
following tests:
NOTE 2 In some cases, the following tests can be carried out simultaneously.
a) End-inspiratory and end-expiratory pressure errors
1) Set up the VENTILATOR as shown in Figure 201.101.
2) If applicable, determine or input the VBS compliance required for compliance correction as
indicated in the instructions for use and activate this correction. If a HUMIDIFIER is used, fill the
HUMIDIFIER to the maximum water level prior to determining the VBS compliance.
3) Utilize the test parameters and settings of the first applicable row (selected by typical intended
DELIVERED VOLUME) of Table 201.105. Wait until steady-state conditions are achieved.
NOTE 3 Intentionally, for some of these tests (i.e. those utilizing a VBS with a large compliance and a high
resistance), the end‐expiratory flow will not reach zero.
4) Determine the AIRWAY PRESSURE at the end of the inspiratory phase as the average over the
preceding 50 ms.
5) Compare the result with the pressure setting for the test. Confirm that the resulting difference is

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
6) Determine the DELIVERED VOLUME, for example, by integration of the flow signal provided by a
calibrated flow sensor located at the PATIENT-CONNECTION PORT or for a VENTILATOR that indicates a
leakage-compensated DELIVERED VOLUME by the product of the test lung compliance and the
measured change of lung pressure, if necessary, compensated for temperature effects due to fast
compression of the gas.
NOTE 4 Additional information on the construction of an isothermal test lung is found in Reference [34].
7) Determine the accuracy of the DELIVERED VOLUME MONITORING EQUIPMENT by comparing its reading
to the DELIVERED VOLUME determined in 6). Refer to 201.12.1.104.
8) Determine the PEEP as the average of the AIRWAY PRESSURE measurements over the last 50 ms of the
expiratory phase.
9) Compare the result with the PEEP setting for the test. Confirm that the resulting difference is
10) Repeat 2) to 9) for 30 consecutive breaths.
11) Repeat 2) to 10) for each applicable row (selected by intended DELIVERED VOLUME) of
Table 201.105.
12) If a HUMIDIFIER is included in the VBS, repeat the AIRWAY PRESSURE tests with the minimum
HUMIDIFIER water level without re-determining the VBS compliance.
13) If the VENTILATOR permits operation without compliance correction, repeat 2) to 12) without
compliance correction.
b) FiO2 error
14) If provided with a control for the setting of the inspiratory oxygen concentration, the accuracy of
the inspiratory O2 concentration of the gas delivered is assessed by placing the sensor of an O2
concentration measuring device at the PATIENT-CONNECTION PORT or inside the test lung. If the
sensor is located at the PATIENT-CONNECTION PORT, the value of the concentration is the flow-
weighted average concentration as a function of flow during the inspiratory phase.
15) Compare the measured O2 concentration with the FiO2 setting. Confirm that the difference is
NOTE 5 If the sensor is located inside the test lung, care should be taken to allow sufficient time for the gas
mixture in the test lung to reach a stable concentration.
NOTE 6 If the sensor is located in the tubing system, care should be taken to ensure that the measuring
device has a sufficiently fast response to permit determination of the flow‐weighted average concentration
during the inspiratory phase.
NOTE 7 If the O2 concentration measuring device has pressure dependencies, compensate for these
dependencies.
16) Obtain the FiO2 error by comparing the FiO2 setting to the measured value for each test in a)
above.
17) Compare each result to the tolerance indicated in the instructions for use.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Table 201.105 — Pressure-controlled breath TYPE TEST settings

Test Intended Test lung parameters VENTILATOR settings
number DELIVERED
Compliance Linear[30] Leakageb Ventilatory INSPIRATORY Pressured FiO2e PEEP
VOLUMEa [42][45] (ml/min) frequency TIMEc
(ml(hPa)‐1) (hPa) (%) (hPa)
(ml) Resistance
± 10 % ±10 % (breaths/mi (s)
(hPa(l/s)‐1)
n)
± 10 %
1 500 50 5 0 20 1 10 28 5
2 500 50 20 0 20 1 15 35 10
3 500 20 5 0 20 1 25 35 5
4 500 20 20 0 20 1 25 28 10
5 500 50 5 5 000 20 1 25 28 5
6 500 50 20 10 000 20 1 25 35 10
7 300 20 20 0 20 1 15 28 5
8 300 20 50 0 20 1 25 35 10
9 300 10 50 0 20 1 30 35 5
10 300 20 20 3 000 20 1 25 28 5
11 300 20 50 6 000 20 1 25 35 10
12 200 10 20 0 20 1 25 28 10
13 50 3 20 0 30 0,6 15 28 5
14 50 3 50 0 30 0,6 15 28 10
15 50 3 200 0 30 0,6 25 35 5
a The volume in this column is intended to be used for the selection of the test conditions and parameters based on the intended DELIVERED
VOLUME of the VENTILATOR.
b For the purpose of this test, the VBS under test is set up with the leakage at a constant pressure of 20 hPa.
c The rise time of the VENTILATOR should be set to a value that ensures that the set pressure can be reached within the INSPIRATORY TIME.
d For the purposes of this test, the set pressure is relative to set PEEP.
e If the VENTILATOR is not provided with a control for the setting of the inspiratory oxygen concentration, room air is used.
201.12.1.104 * DELIVERED VOLUME MONITORING EQUIPMENT

The VENTILATOR shall be equipped with DELIVERED VOLUME MONITORING EQUIPMENT. The indication of the
value of the DELIVERED VOLUME MONITORING EQUIPMENT and associated ALARM CONDITIONS may be disabled
when the expired volume MONITORING EQUIPMENT is in use. The accuracy of the DELIVERED VOLUME
MONITORING EQUIPMENT shall be disclosed in the instructions for use. The indicated value of DELIVERED
VOLUME may be displayed on OPERATOR demand.
The DELIVERED VOLUME MONITORING EQUIPMENT shall be equipped with an ALARM SYSTEM that detects at
least a MEDIUM PRIORITY ALARM CONDITION to indicate when the low DELIVERED VOLUME ALARM LIMIT is
reached. The DELIVERED VOLUME MONITORING EQUIPMENT may be equipped with an ALARM SYSTEM that
starts with a LOW PRIORITY ALARM CONDITION to indicate when the DELIVERED VOLUME reaches the ALARM
LIMIT and, if this state continues, escalates to a MEDIUM PRIORITY ALARM CONDITION.
The DELIVERED VOLUME ALARM LIMIT may be pre‐adjusted, RESPONSIBLE ORGANIZATION‐adjustable, OPERATOR‐
adjustable, VENTILATOR‐adjustable, or a combination of OPERATOR‐adjustable and VENTILATOR‐adjustable.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
If the ALARM LIMIT is adjustable by the VENTILATOR, a summary description of the algorithm that
determines the ALARM LIMIT value shall be disclosed in the instructions for use.
NOTE Depending on the type of ventilation mode being utilized, there can be more than one active ALARM
LIMIT.
Check compliance with functional testing and the following.

Select and set up the worst-case VBS configuration indicated in the instructions for use.
EXAMPLE Minimum and maximum VBS compliance.
Confirm that the DELIVERED VOLUME MONITORING EQUIPMENT accuracy as measured in 201.12.1.102 a) 6) and
201.12.1.103 a) 7), as applicable, is within the accuracy disclosed in the instructions for use.
For a VBS that includes a HUMIDIFIER, repeat the tests at the minimum and maximum water levels (2 sets of
tests for a HUMIDIFIER).
201.12.4 Protection against hazardous output
201.12.4.4 Incorrect output
Amendment (replace the compliance check with):
Any pressure setting change and its relation to any other pressure settings shall be displayed while the
setting is performed.
Any setting that affects the I:E ratio or INSPIRATORY TIME shall be displayed with the I:E ratio and
INSPIRATORY TIME while the setting is performed.
The VENTILATOR shall provide the RESPONSIBLE ORGANIZATION a means to allow the supervising clinician or
the healthcare professional OPERATOR to have direct access to the ventilation settings and ALARM LIMITS
(see 201.109).
The VENTILATOR shall provide the RESPONSIBLE ORGANIZATION or the supervising clinician or the
healthcare professional OPERATOR a means to restrict the LAY OPERATOR from adjusting the ventilation
settings and ALARM SETTINGS (see 201.109).
EXAMPLES Settings needing protection include ventilatory frequency, I:E ratio, INSPIRATORY TIME, adjustable
pressure limitation, high inspiratory pressure ALARM LIMIT, and mode breath type.
Compliance is checked by functional testing and inspection of the RISK MANAGEMENT FILE.
201.12.4.101 Oxygen monitor
If provided with a control for the setting of the inspiratory oxygen concentration, the VENTILATOR shall
either
— be equipped with O2 MONITORING EQUIPMENT for the measurement of the inspiratory oxygen
concentration (e.g. in the inspiratory limb or at the PATIENT‐CONNECTION PORT), or
— if not so equipped, the instructions for use shall contain a statement to the effect that the
VENTILATOR is to be equipped with O2 MONITORING EQUIPMENT for measurement of the inspiratory
oxygen concentration (e.g. in the inspiratory limb or at the PATIENT‐CONNECTION PORT) that complies
with ISO 80601‐2‐55:2011 before being put into service.
Unless the O2 MONITORING EQUIPMENT is an integral part of the VENTILATOR, information on where to
connect the O2 MONITORING EQUIPMENT shall be disclosed in the instructions for use.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
The O2 MONITORING EQUIPMENT shall

— comply with ISO 80601‐2‐55:2011, and
— be equipped with an ALARM SYSTEM that detects a high oxygen level ALARM CONDITION.
NOTE A low oxygen level ALARM CONDITION is required by ISO 80601‐2‐55.
Check compliance by application of the tests of ISO 80601-2-55:2011 and, if appropriate, inspection of the
instructions for use.
201.12.4.102 * Measurement of AIRWAY PRESSURE
The VENTILATOR shall be equipped with MONITORING EQUIPMENT to indicate the AIRWAY PRESSURE. The site
of actual measurement can be anywhere in the VENTILATOR BREATHING SYSTEM, but the indicated value
shall be referenced to the PATIENT‐CONNECTION PORT. Under steady‐state conditions, the indicated AIRWAY
PRESSURE shall be accurate to within ± (2 hPa (2 cmH2O) + 4 %) of the actual reading.
The AIRWAY PRESSURE MONITORING EQUIPMENT shall be equipped with an ALARM SYSTEM that detects at least
a MEDIUM PRIORITY ALARM CONDITION to indicate when the low‐AIRWAY PRESSURE ALARM LIMIT is reached.
The AIRWAY PRESSURE MONITORING EQUIPMENT may be equipped with an ALARM SYSTEM that starts with a
LOW PRIORITY ALARM CONDITION to indicate when the AIRWAY PRESSURE reaches the ALARM LIMIT and, if this
state continues, escalates to a MEDIUM PRIORITY ALARM CONDITION.
The AIRWAY PRESSURE ALARM LIMIT may be pre‐adjusted, RESPONSIBLE ORGANIZATION‐adjustable, OPERATOR‐
If the ALARM LIMIT is adjustable by the VENTILATOR, a summary description of the algorithm that
determines the ALARM LIMIT value shall be disclosed in the instructions for use.
LIMIT.
Check compliance by functional testing.

201.12.4.103 * Measurement of expired volume and low-volume ALARM CONDITIONS
A VENTILATOR intended to provide a DELIVERED VOLUME greater than 50 ml shall be equipped with
MONITORING EQUIPMENT for indicating the volume expired through the PATIENT‐CONNECTION PORT unless
expiratory end‐tidal CO2 MONITORING EQUIPMENT (201.12.1.104) or an ALARM SYSTEM that detects a
TECHNICAL ALARM CONDITION to indicate when conditions in the VBS reach the ALARM LIMIT for high leakage
(201.12.4.111) is in use. The indication of the value of the expired volume MONITORING EQUIPMENT and
associated ALARM CONDITIONS may be disabled when the DELIVERED VOLUME MONITORING EQUIPMENT is in
use. The accuracy of expired volume MONITORING EQUIPMENT shall be disclosed in the instructions for use.
The MONITORING EQUIPMENT for indicating the volume expired through the PATIENT‐CONNECTION PORT may
be provided by an option.
The expired volume MONITORING EQUIPMENT shall be equipped with an ALARM SYSTEM that detects at least
MEDIUM PRIORITY ALARM CONDITIONS to indicate when the low‐expired volume ALARM LIMIT and the high‐
expired volume ALARM LIMIT are reached. The expired volume MONITORING EQUIPMENT may be equipped
with an ALARM SYSTEM that starts with LOW PRIORITY ALARM CONDITIONS to indicate when the expired
volume reaches either ALARM LIMIT and, if this state continues, escalates to MEDIUM PRIORITY ALARM
CONDITIONS.
The expired volume ALARM LIMITS may be pre‐adjusted, RESPONSIBLE ORGANIZATION‐adjustable, OPERATOR‐
If the ALARM LIMITS are adjustable by the VENTILATOR, a summary description of the algorithm that
determines the ALARM LIMIT values shall be disclosed in the instructions for use.
LIMIT.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Check compliance by functional testing using the test conditions described in Table 201.103 and
Table 201.104 and inspection of the instructions for use. Select and set up the worst-case VBS configuration
indicated in the instructions for use.
EXAMPLE Minimum and maximum VBS compliance.
For testing with a HUMIDIFIER, repeat the tests at the minimum and maximum water levels (two sets of tests
for a HUMIDIFIER).
201.12.4.104 * Expiratory end-tidal CO2 MONITORING EQUIPMENT
Notwithstanding the requirements of 201.12.4.103 as an alternative to 201.12.4.103, a VENTILATOR may
either
— be equipped with CO2 MONITORING EQUIPMENT for the measurement of expiratory carbon dioxide
concentration (e.g. in the expiratory limb or at the PATIENT‐CONNECTION PORT) that is integral to the
VENTILATOR, or
— be equipped with a FUNCTIONAL CONNECTION to CO2 MONITORING EQUIPMENT that permits the
VENTILATOR to determine of when the CO2 MONITORING EQUIPMENT is in use.
CO2 MONITORING EQUIPMENT shall comply with ISO 80601‐2‐55:2011.

Where the CO2 MONITORING EQUIPMENT is not an integral part of the VENTILATOR, the instructions for use
shall include the following:
— statement to the effect that the VENTILATOR is to be provided with CO2 MONITORING EQUIPMENT that
complies with ISO 80601‐2‐55:2011 before being put into service;
— information on where to connect the CO2 MONITORING EQUIPMENT.

201.12.4.105 * MAXIMUM LIMITED PRESSURE PROTECTION DEVICE
A PROTECTION DEVICE shall be provided to prevent the AIRWAY PRESSURE from exceeding the MAXIMUM
LIMITED PRESSURE under both NORMAL CONDITION and SINGLE FAULT CONDITION. The MAXIMUM LIMITED
PRESSURE shall not exceed 90 hPa (90 cmH2O).

201.12.4.106 High-pressure ALARM CONDITION and PROTECTION DEVICE
The VENTILATOR shall be equipped with MONITORING EQUIPMENT with an ALARM SYSTEM that detects a high‐
AIRWAY PRESSURE ALARM CONDITION to indicate when the high‐pressure limit for AIRWAY PRESSURE is
reached. The ALARM LIMIT may be independently adjustable, connected to an adjustable pressure
limitation or may be related to the set pressure of the VENTILATOR. If the ALARM LIMIT is independently
adjustable, it shall not be possible to set the ALARM LIMIT to a value less than that of the adjustable
pressure limitation. The maximum ALARM CONDITION DELAY of the high‐AIRWAY PRESSURE ALARM CONDITION
shall not exceed three consecutive breaths.
The high‐AIRWAY PRESSURE ALARM CONDITION shall either be HIGH PRIORITY or MEDIUM PRIORITY and escalate
to HIGH PRIORITY if the high‐AIRWAY PRESSURE ALARM CONDITION exists for longer than ten consecutive
breaths or 30 s, whichever is less. The priority can escalate sooner than ten consecutive breaths or 30 s.
PATIENT‐generated transient pressure increases should not cause the high‐pressure limit ALARM
CONDITION.
EXAMPLE Transient pressure increase caused by the PATIENT coughing.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Each time the HIGH PRIORITY high‐pressure ALARM LIMIT for AIRWAY PRESSURE is reached, the VENTILATOR
shall act to reduce the pressure at the PATIENT‐CONNECTION PORT to the level of the set PEEP. The interval
from the moment that the AIRWAY PRESSURE equals the high‐pressure ALARM LIMIT to the moment that the
pressure starts to decline shall not exceed 200 ms. During SINGLE FAULT CONDITION, the AIRWAY PRESSURE
may go below the set PEEP level.
201.12.4.107 * Obstruction ALARM CONDITION
The VENTILATOR shall be equipped with MONITORING EQUIPMENT with an ALARM SYSTEM that detects a
TECHNICAL ALARM CONDITION to indicate when conditions in the VBS reach the ALARM LIMIT for obstruction.
EXAMPLES ALARM CONDITION to warn of the following:
— obstructed inspiratory breathing tube or expiratory gas pathway;
— blocked exhalation valve;
— blocked expiratory BREATHING SYSTEM FILTER.
The obstruction TECHNICAL ALARM CONDITION shall be HIGH PRIORITY. The maximum ALARM CONDITION DELAY
shall be no more than two breath cycles or 5 s, whichever is greater.
Whenever the obstruction ALARM CONDITION occurs, the VENTILATOR shall, within no more than one
breath cycle, reduce the AIRWAY PRESSURE to either atmospheric pressure or the set PEEP level. The
VENTILATOR should be equipped with a PROTECTION DEVICE to allow spontaneous breathing when
obstruction occurs. If equipped with the PROTECTION DEVICE, the pressure drop measured at the PATIENT‐
CONNECTION PORT, with all recommended ACCESSORIES in place, shall not exceed 6,0 hPa (6,0 cmH2O) at
the following flowrates:
— 30 l/min for a VENTILATOR intended to provide a DELIVERED VOLUME, Vdel ≥ 300 ml;
— 15 l/min for a VENTILATOR intended to provide a DELIVERED VOLUME, 300 ml ≥ Vdel ≥ 50 ml;
— 2,5 l/min for a VENTILATOR intended to provide a DELIVERED VOLUME, Vdel ≤ 50 ml.
The means by which the obstruction ALARM CONDITION is determined and a means to test it shall be
described in the ACCOMPANYING DOCUMENT.
Check compliance by functional testing with each VBS indicated in the instructions for use, according to the
test method described in the ACCOMPANYING DOCUMENT.
201.12.4.108 * Partial-occlusion ALARM CONDITION
The VENTILATOR should be equipped with MONITORING EQUIPMENT with an ALARM SYSTEM that detects a
TECHNICAL ALARM CONDITION to indicate when the expiratory gas pathway is partially occluded.
A summary description of the means by which the expiratory‐gas‐pathway‐partial‐occlusion ALARM

CONDITION is determined shall be described in the ACCOMPANYING DOCUMENT.
Check compliance by functional testing with each VBS indicated in the instructions for use, according to the
test method described in the ACCOMPANYING DOCUMENT.
201.12.4.109 Hypoventilation ALARM CONDITION
The VENTILATOR shall be equipped with MONITORING EQUIPMENT with an ALARM SYSTEM that detects an
ALARM CONDITION to indicate hypoventilation. A low respiratory breathing rate may be used for the
hypoventilation ALARM CONDITION.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
NOTE The hypoventilation ALARM CONDITION can be determined, inter alia, by the measurement of the
variations of AIRWAY PRESSURE (201.12.4.102), expiratory volume (201.12.4.103), DELIVERED VOLUME (201.12.1.103),
or CO2 (201.12.4.104) or by an INTELLIGENT ALARM SYSTEM utilizing one or more variables.

201.12.4.110 Continuing positive-pressure ALARM CONDITION
The VENTILATOR shall be equipped with MONITORING EQUIPMENT with an ALARM SYSTEM that detects an
ALARM CONDITION to indicate an unintended continuing positive pressure lasting for more than 17 s. The
continuing positive pressure ALARM CONDITION shall be at least MEDIUM PRIORITY.
The technical description shall disclose a summary of the algorithm used to determine the continuing
positive‐pressure ALARM CONDITION.
201.12.4.111 * High leakage ALARM CONDITION
The VENTILATOR shall be equipped with an ALARM SYSTEM that detects a TECHNICAL ALARM CONDITION to
indicate when conditions in the VBS reach the ALARM LIMIT for high leakage. The high leakage TECHNICAL
ALARM CONDITION shall be at least MEDIUM PRIORITY. The high leakage TECHNICAL ALARM CONDITION may be
disabled when the DELIVERED VOLUME MONITORING EQUIPMENT is in use.
201.12.101 * Protection against accidental adjustments
Means of protection against accidental adjustment of controls that can create a HAZARDOUS SITUATION,
including against accidently turning the VENTILATOR off, shall be provided. Turning off the ventilation
shall require at least a sequence of two very deliberate actions.
NOTE 1 This can be accomplished by means of hardware or software or a combination of both.
NOTE 2 This can be accomplished by two dedicated confirmation actions.
It shall be possible to set all VENTILATOR parameters prior to starting any ventilation mode.
To switch on the VENTILATOR and to start the ventilation shall require two different actions.
The USABILITY of these means of protection shall be evaluated in the USABILITY ENGINEERING PROCESS.
NOTE 3 The requirements for the USABILITY ENGINEERING PROCESS are found in IEC 60601–1:2005+AMD1:2012,
12.2 and IEC 60601–1‐6:2010+AMD1:2013.
Check compliance by functional testing and inspection of USABILITY ENGINEERING FILE.

201.13 HAZARDOUS SITUATIONS and fault conditions
201.13.2.101 * Additional specific SINGLE FAULT CONDITIONS
A VENTILATOR shall be so constructed that the following SINGLE FAULT CONDITIONS shall not cause an
unacceptable RISK:
— a disruption of the gas delivery to the VENTILATOR support equipment, or
— removal or failure of an OPERATOR‐detachable BREATHING SYSTEM FILTER.
Check compliance by functional testing and inspection of RISK MANAGEMENT FILE.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
201.13.101 Failure of one gas supply to a VENTILATOR

Following the failure of one external gas supply, a VENTILATOR equipped with a means to deliver inspired
oxygen concentrations greater than ambient shall automatically use the remaining gas supply, and
otherwise maintain normal operation.
NOTE For the purpose of this part of ISO 80601, the failure of the blower is not considered as the failure of a
gas supply.

201.13.102 * Independence of ventilation control function and related RISK CONTROL measures
A SINGLE FAULT CONDITION shall not cause the ventilation‐control function and the corresponding
PROTECTION DEVICE to fail simultaneously.
A SINGLE FAULT CONDITION shall not cause either of the following to fail in such a way that the loss of the
ventilation‐control function is not detected:
— the ventilation‐control function and the corresponding MONITORING EQUIPMENT;
— the ventilation‐control function and the corresponding ALARM SYSTEM.
Check compliance by inspection and functional testing.

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
201.14.1 General
Amendment (extend the last paragraph prior to the compliance check with):
The ventilation control SOFTWARE ITEMS of the VENTILATOR PESS without an independent hardware RISK
CONTROL measure shall be considered as software safety Class C as defined in IEC 62304:2006.
201.15 Construction of ME EQUIPMENT

201.15.101 Mode of operation
A VENTILATOR shall be suitable for continuous operation.
201.15.102 ACCESSORY pre-use check
A VENTILATOR shall be equipped with means that allow the determination of whether or not the VBS is
suitable for use. Additional requirements are also found in 201.7.9.2.8.101. This means might require
OPERATOR action.

201.15.103 Integrated dual-limb VBS
A VENTILATOR should be designed in such a way as to allow the use of an integrated VBS, which allows the
continuous monitoring of expired volume (201.12.4.103) or the expiratory end‐tidal CO2 monitoring
(201.12.4.104), while in use.
EXAMPLE A VENTILATOR designed for use of a coaxial breathing system or a single limb breathing system
which includes or provides connect ability to expiratory expired volume or expiratory end‐tidal CO2 in the close
vicinity of the PATIENT‐CONNECTION PORT.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
201.16 ME SYSTEMS
201.16.1.101 Additional general requirements for ME SYSTEMS
ACCESSORIES connected to the VBS shall be considered to form an ME SYSTEM with the VENTILATOR.
Check compliance by application of the relevant tests of IEC 60601-1:2005+AMD1:2012.
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
New clauses:
201.101 Gas connections
201.101.1 Connection to the MEDICAL GAS PIPELINE SYSTEM
If an OPERATOR‐detachable hose assembly is provided for connection between the VENTILATOR and a
MEDICAL GAS PIPELINE SYSTEM, it shall comply with ISO 5359:2008.
Check compliance by application of the tests of ISO 5359:2008.

201.101.2 VBS connectors
201.101.2.1 * General
A conical VBS connector shall be either a 15 mm or a 22 mm connector complying with ISO 5356‐1:2004
or not engage with those connectors.
A non‐conical connector shall not engage with a conical connector complying with ISO 5356‐1:2004
unless it complies with the engagement, disengagement, and leakage requirements of that standard.
The VBS, its parts, or ACCESSORIES, shall not be equipped with connectors that permit a FUNCTIONAL
CONNECTION with a connector complying with ISO 594‐1:1986 or ISO 594‐2:1998 7 .
Check compliance by application of the tests of ISO 5356-1:2004 and functional testing.
201.101.2.2 Other named ports
201.101.2.2.1 PATIENT-CONNECTION PORT
The PATIENT‐CONNECTION PORT shall be one either of the following:
a) female 15 mm conical connector complying with ISO 5356‐1:2004;
b) coaxial 15 mm/22 mm conical connector complying with ISO 5356‐1:2004.
Check compliance by application of the tests of ISO 5356‐1:2004.

201.101.2.2.2 GAS OUTPUT PORT and GAS RETURN PORT
The GAS OUTPUT PORT and the GAS RETURN PORT shall be one of the following or not engage with those
connectors:
a) male 22 mm conical connector complying with ISO 5356‐1:2004;
b) male 15 mm conical connector complying with ISO 5356‐1:2004;
7 To be replaced by ISO 80369‐7.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
c) coaxial 15 mm/22 mm conical connector complying with ISO 5356‐1:2004.
Check compliance by application of the tests of ISO 5356-1:2004.

201.101.2.2.3 * Manual ventilation port
The VENTILATOR shall not be equipped with a MANUAL VENTILATION PORT.
201.101.2.2.4 FLOW-DIRECTION-SENSITIVE COMPONENTS
Any OPERATOR‐detachable FLOW‐DIRECTION‐SENSITIVE COMPONENT of the VBS shall be so designed that it
cannot be fitted in such a way that it presents an unacceptable RISK to the PATIENT.
Check compliance by inspection of OPERATOR-detachable FLOW-DIRECTION-SENSITIVE COMPONENTS and
inspection of the RISK MANAGEMENT FILE.
201.101.2.2.5 ACCESSORY port
If provided, each ACCESSORY port shall comply with ISO 80369‐1:2010 and shall be provided with a
means to secure the ACCESSORY in position and a means to secure closure after removal of the ACCESSORY.
NOTE 1 It is expected that the RESP‐125 connector of ISO 80369‐2 will meet this criterion.
NOTE 2 This port is generally used for measuring pressure, sampling of gases, or for introduction of
therapeutic aerosols.
Check compliance by inspection and application of the tests of ISO 80369-1:2010.

201.101.2.2.6 Monitoring probe port
If a port is provided for introduction of a monitoring probe, it shall not be compatible with connectors
specified in ISO 5356‐1:2004 and shall be provided with a means to secure the probe in position and a
means to secure closure after removal of the probe.
201.101.2.2.7 Gas EXHAUST PORT
If a connector is provided for the gas EXHAUST PORT, it shall be a 30 mm connector complying with
ISO 5356‐1:2004.
NOTE A 30‐mm connector complying with ISO 5356‐1:2004 is suitable for connection to ANAESTHESIA GAS
SCAVENGING SYSTEM (AGSS) that complies with ISO 80601‐2‐13:2011.
A VENTILATOR shall be designed so that any provided gas EXHAUST PORT is not obstructed during use.
201.101.2.2.8 Oxygen inlet port
An oxygen inlet connector of the VENTILATOR, which is not intended for direct connection to the MEDICAL
GAS PIPELINE SYSTEM (201.101.1) and is OPERATOR‐accessible without the use of a TOOL, shall comply with
ISO 80369‐1:2010. A VENTILATOR with this inlet connector shall maintain BASIC SAFETY and ESSENTIAL
PERFORMANCE with oxygen supply systems up to 600 kPa, in NORMAL CONDITION.
NOTE It is expected that the RESP‐6000 connector of ISO 80369‐2 will meet this criterion.
Check compliance by functional testing and application of the tests of ISO 80369-1:2010.

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ISO 80601-2-72:2015(E)
201.102 Requirements for the VBS and ACCESSORIES

201.102.1 * General
All VENTILATOR BREATHING SYSTEMS, their parts, and ACCESSORIES shall comply with the requirements of
this part of ISO 80601, whether they are produced by the MANUFACTURER of the VENTILATOR or by another
entity (“third‐party manufacturer” or healthcare provider).
Check compliance by the tests of this part of ISO 80601.
201.102.2 Labelling
The MODEL OR TYPE REFERENCE of at least one compatible VENTILATOR shall be disclosed in the
ACCOMPANYING DOCUMENT provided with each VBS or ACCESSORY, compliant with 201.102.1.
Statements shall be included in the ACCOMPANYING DOCUMENT of each VENTILATOR BREATHING SYSTEM, part,
or ACCESSORY to the effect that
a) ventilator breathing systems, their parts, and accessories are validated for use with specific
ventilators,
b) incompatible parts can result in degraded performance, and
c) the responsible organization is accountable for the compatibility of the ventilator and all of the
parts and accessories used to connect to the patient before use.
Check compliance by inspection of the ACCOMPANYING DOCUMENT.

201.102.3 Breathing tubes
Breathing tubes, other than heated breathing tubes, intended for use in the VBS shall comply with
ISO 5367:2000.
NOTE Heated breathing tubes are covered by ISO 8185.

201.102.4 * Humidification
201.102.4.1 HUMIDIFIER
Any HUMIDIFIER, including heated breathing tubes, either incorporated into the VENTILATOR or
recommended for use with the VENTILATOR, shall comply with ISO 8185:2007. 8
201.102.4.2 HEAT AND MOISTURE EXCHANGER (HME)
Any HME, either incorporated into the VBS or recommended for use with the VBS, shall comply with
ISO 9360‐1:2000 or ISO 9360‐2:2001.
Check compliance by application of the tests of ISO 9360-1:2000 or ISO 9360-2:2001.
201.102.5 BREATHING SYSTEM FILTERS (BSF)
Any BSF, either incorporated into the VENTILATOR or recommended for use with the VENTILATOR, shall
comply with the relevant requirements of ISO 23328‐1:2003 and ISO 23328‐2:2002.
Check compliance by application of the tests of ISO 23328-1:2003 and ISO 23328-2:2002.
8 To be replaced by ISO 80601‐2‐74.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
201.102.6 VENTILATOR BREATHING SYSTEMS

201.102.6.1 Leakage from VBS
The unintended leakage from the VBS external to the VENTILATOR shall not exceed the following and at a
continuous pressure of (60 ± 3) hPa ((60 ± 3) cmH2O):
— 70 ml/min if specified for a VENTILATOR with an intended DELIVERED VOLUME ≥300 ml;
— 40 ml/min if specified for a VENTILATOR with an intended DELIVERED VOLUME between 50 ml and
300 ml;
— 30 ml/min if specified for a VENTILATOR with an intended DELIVERED VOLUME ≤50 ml.
Check compliance by the following test.

a) Set up the VBS for the intended application as indicated in the instructions for use.
b) Seal all ports.
c) Connect a pressure-measuring device and introduce the air into the VBS until a pressure of 60 hPa
(60 cmH2O) is reached.
d) Adjust the flow of air to stabilize the pressure and record the leakage flow.
201.102.6.2 * Non-invasive ventilation

The instructions for use for a VENTILATOR intended for non‐invasive ventilation shall include a warning
statement to the effect that the exhaled volume of the PATIENT can differ from the indicated exhaled
volume due to leaks around the MASK.
201.103 * Spontaneous breathing during loss of power supply
A PROTECTION DEVICE shall be provided to allow spontaneous breathing when normal ventilation is
compromised as a result of the electrical or pneumatic supply power being outside the values necessary
for normal operation.
Under these conditions, the inspiratory and expiratory pressure drop measured at the PATIENT‐
CONNECTION PORT with all recommended ACCESSORIES in place shall not exceed 6,0 hPa (6,0 cmH2O) at of
the following flowrates:
— 30 l/min for a VENTILATOR intended to provide a DELIVERED VOLUME, Vdel ≥ 300 ml;
— 15 l/min for a VENTILATOR intended to provide a DELIVERED VOLUME, 300 ml ≥ Vdel ≥ 50 ml;
— 2,5 l/min for a VENTILATOR intended to provide a DELIVERED VOLUME, Vdel ≤ 50 ml.
NOTE This requirement is intended to allow the PATIENT to breathe spontaneously under compromised
conditions.
Check compliance by functional testing and measurement of flow, pressure, and resistance at the PATIENT-
CONNECTION PORT with that combination of ACCESSORIES indicated in the instructions for use which produces
the greatest pressure drop.
201.104 * Training
In the application of the requirements of IEC 62366:2007, Clause 7, training shall be considered
necessary for both the LAY OPERATOR and the designee of the RESPONSIBLE ORGANIZATION.

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ISO 80601-2-72:2015(E)
NOTE Requirements for training are found in IEC 62366:2007, Clause 7.
Check compliance by inspection of the ACCOMPANYING DOCUMENT.

201.105 * Indication of duration of operation
The VENTILATOR shall have means to indicate visually, either automatically or by OPERATOR action, the
cumulative hours of operation of the VENTILATOR. The VENTILATOR should also have means by OPERATOR
action to indicate visually the time until the next recommended preventive maintenance.
201.106 FUNCTIONAL CONNECTION
201.106.1 General
BASIC SAFETY and ESSENTIAL PERFORMANCE shall be maintained if the FUNCTIONAL CONNECTION of a
VENTILATOR is disrupted or if the equipment connected to those parts fails.

201.106.2 * Connection to an electronic health record
A VENTILATOR should be equipped with a FUNCTIONAL CONNECTION that permits data transmission from
the VENTILATOR to, for example, an electronic health record.
201.106.3 * Connection to a DISTRIBUTED ALARM SYSTEM
A VENTILATOR shall be equipped with a FUNCTIONAL CONNECTION that permits connection to a DISTRIBUTED
ALARM SYSTEM.

201.106.4 Connection for remote control
A VENTILATOR may be equipped with a FUNCTIONAL CONNECTION for connection for external control of the
VENTILATOR.
201.107 Display loops

201.107.1 Pressure-volume loops
If a VENTILATOR is provided with the display of pressure‐volume loops, the graph shall use the following:
— DELIVERED VOLUME on the vertical axis;
— AIRWAY PRESSURE on the horizontal axis.
Positive values shall be on the top and the right of the display. Increases in DELIVERED VOLUME shall be
positive values. The volume shall be reset to the origin at the beginning of each breath.
201.107.2 Flow-volume loops
If a VENTILATOR is provided with the display of flow‐volume loops, the graph shall use the following:
— flowrate on the vertical axis;
— DELIVERED VOLUME on the horizontal axis.
Positive values shall be on the top and the right of the display. Gas flow to the PATIENT (inspiratory flow)
and increases in DELIVERED VOLUME shall be positive values. The volume shall be reset to the origin at the
beginning of each breath.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
The VENTILATOR may be provided with an additional optional display configuration for the flow‐volume
loop where gas flow from the PATIENT (expiratory flow) is represented as a positive value.
201.108 POWER SUPPLY CORDS
Any DETACHABLE POWER SUPPLY CORD or DETACHABLE D.C. POWER CORD of an electrically‐powered
VENTILATOR shall be protected against accidental disconnection from the VENTILATOR under a force of
30 N.
Compliance is checked by inspection and, for a VENTILATOR when provided with an APPLIANCE COUPLER or
detachable d.c. power cord, by the following test.
Subject the detachable cord for one min to an axial pull of force of 30 N.
During the test, the MAINS CONNECTOR becoming disconnected from the APPLIANCE INLET or the detachable
d.c. power cord becoming disconnected from the d.c. input connector of the VENTILATOR is considered a
failure.
201.109 VENTILATOR security
Means of restricting access to changing or to the storage of changes shall be described in the technical
description (see 201.12.4.4).
EXAMPLE 1 Access controlled by a TOOL.
EXAMPLE 2 Access controlled by RESPONSIBLE ORGANIZATION password and a technical description that is
separate from the instructions for use.
EXAMPLE 3 Access controlled by individual OPERATOR password.
NOTE 1 For a password to be considered secure, the owner of the password needs to be capable of changing
the password.
EXAMPLE 4 Access controlled by voice recognition.
EXAMPLE 5 Access controlled by fingerprints.
NOTE 2 Multiple means of restriction can be needed (e.g. one for the RESPONSIBLE ORGANIZATION and one for each
OPERATOR).
Compliance is checked by inspection of the technical description.

202 Electromagnetic disturbances — Requirements and tests
IEC 60601‐1‐2:2014 applies except as follows:
202.4.3.1 * Compliance criteria
Amendment (replace the second dash of 4.3.1 with):
— the VENTILATOR operated using the conditions and test configuration of 201.12.1.102 or
201.12.1.103.
202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS

Amendment (add note to list element b)):
NOTE The requirements of this part of ISO 80601 are not considered deviations or allowances.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Addition:
202.8.1.101 Additional general requirements
The VENTILATOR shall be tested according to the requirements for the HOME HEALTHCARE ENVIRONMENT.
The following degradations, if associated with BASIC SAFETY and ESSENTIAL PERFORMANCE, shall not be
allowed:
— component failures;
— changes in programmable parameters or settings;
— reset to default settings;
— change of operating mode;
EXAMPLES Change of breath type, ventilation mode, ventilatory frequency, I:E ratio.
— initiation of an unintended operation;
— error of DELIVERED VOLUME of individual breaths greater than 35 % and error of the DELIVERED
VOLUME averaged over a one‐minute interval greater than 25 %.
The VENTILATOR can exhibit temporary degradation of performance (e.g. deviation from the
performance indicated in the instructions for use during IMMUNITY testing) that does not affect BASIC
SAFETY or ESSENTIAL PERFORMANCE.
206 Usability
IEC 60601‐1‐6:2010+AMD1:2013 applies except as follows.
For a VENTILATOR, the following shall be considered PRIMARY OPERATING FUNCTIONS:
a) setting the OPERATOR‐adjustable controls;
— setting ALARM LIMITS;
— inactivating ALARM SIGNALS;
— switching between different ventilation modes and breath types;
— setting ventilation control parameters;
EXAMPLES 1 Ventilatory frequency, DELIVERED VOLUME, PEEP, pressure support.
b) observing monitored ventilation parameters;
EXAMPLES 2 AIRWAY PRESSURE and expired volume.
c) configuring the VBS, including connection of the detachable parts of the VBS to the VENTILATOR;
EXAMPLES 3 HUMIDIFIER, nebulizer, water‐trap, tubing, BREATHING SYSTEM FILTER, MONITORING EQUIPMENT.
d) connecting or disconnecting the PATIENT‐CONNECTION PORT of the VBS to the PATIENT‐interface;
e) reprocessing the VBS components;
f) starting the VENTILATOR from power off;

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ISO 80601-2-72:2015(E)
g) turning off the VENTILATOR;
h) performing a basic pre‐use functional check of the VENTILATOR including the ALARM SYSTEM;
i) switching between power sources;
j) testing power sources;
k) connecting and disconnecting the DISTRIBUTED ALARM SYSTEM.
The following functions, if available, shall also be considered PRIMARY OPERATING FUNCTIONS:
l) starting ventilation from standby;
m) activating standby.
The following actions associated with ventilation shall also be considered PRIMARY OPERATING FUNCTIONS:
NOTE For the purposes of this part of ISO 80601, the following functions are considered PRIMARY OPERATING
FUNCTIONS even though they are not performed on the VENTILATOR’S OPERATOR‐EQUIPMENT INTERFACE.
n) humidifying/conditioning gases delivered through the VBS;
o) adding medication to the gas flowing into the PATIENT;
EXAMPLES 4 Nebulisation or injecting fluids into the ancillary port connection of the VBS.
p) suctioning the PATIENT’S airway;
q) providing alternative means of ventilation;
EXAMPLE 5 Use of a manual resuscitator.
r) for a TRANSIT OPERABLE VENTILATOR, positioning the PATIENT and the VENTILATOR on the wheelchair.
208 General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
IEC 60601‐1‐8:2006+AMD1:2012 applies except as follows.
208.6.8.3.101 Additional requirements for global indefinite ALARM SIGNAL inactivation states
A VENTILATOR shall not be equipped with a means to initiate a global ALARM OFF while connected to a
PATIENT.

208.6.8.4.101 * Additional requirements for termination of ALARM SIGNAL inactivation
The duration of AUDIO PAUSED or ACKNOWLEDGED for the ALARM CONDITIONS required by this part of
ISO 80601 shall not exceed 120 s without OPERATOR intervention.
NOTE This permits an OPERATOR to deliberately extend the duration of AUDIO PAUSED by direct action.

208.6.12.101 * Additional requirements for ALARM SYSTEM logging
Notwithstanding the requirements of IEC 60601‐1‐8:2006+AMD1:2012, the VENTILATOR shall

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
— be equipped with an ALARM SYSTEM log for all ALARM CONDITIONS and all ALARM SIGNAL inactivation
states with a capacity of at least 1 000 events,
— not lose the contents of the ALARM SYSTEM log during a loss of power for less than 365 d unless
deleted by RESPONSIBLE ORGANIZATION action, and
— not permit the LAY OPERATOR to erase the contents of the ALARM SYSTEM log.
This log shall also include at least the following events:

— change of ventilation settings;
— change of ALARM SETTINGS;
— power supply source change;
— access mode;
— result of the last pre‐use check.
Check compliance by inspection and functional testing.

211 Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment
IEC 60601‐1‐11:2015 applies except as follows:
211.8.4.101 * Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT
Notwithstanding the requirements of IEC 60601‐1‐11:2015, 8.4, the VENTILATOR shall be equipped with
the following:
— an INTERNAL ELECTRICAL POWER SOURCE capable of powering the VENTILATOR for at least 2 h when the
SUPPLY MAINS falls outside the values necessary to maintain normal operation;
— a means of determining the state of this INTERNAL ELECTRICAL POWER SOURCE.
As the INTERNAL ELECTRICAL POWER SOURCE depletes, but at least 15 min prior to the loss of all power, the
VENTILATOR shall be equipped with a means to detect an impending INTERNAL ELECTRICAL POWER SOURCE
failure ALARM CONDITION. It shall be of at least MEDIUM PRIORITY. The impending INTERNAL ELECTRICAL
POWER SOURCE failure ALARM CONDITION priority shall escalate to HIGH PRIORITY at least 5 min prior to the
depletion of the INTERNAL ELECTRICAL POWER SOURCE. There shall be at least 5 min between the beginnings
of these two ALARM CONDITIONS. The instructions for use shall state the time between loss of all power
and the generation of ALARM SIGNALS for the impending INTERNAL ELECTRICAL POWER SOURCE failure
warning ALARM CONDITION.
NOTE The OPERATOR needs sufficient time “prior to the loss of all power” to take action to ensure that
alternative arrangements can be made to continue the life‐supporting function of the VENTILATOR.
The instructions for use shall disclose the following:

a) the operational time of the VENTILATOR when powered from each power source under the following
conditions:
— fully charged power source;

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
— DELIVERED VOLUME, Vdel = 800 ml or the largest RATED DELIVERED VOLUME, whichever is smaller;
— ventilatory frequency, f = 20 min‐1;
— I:E ratio = 1:2;
— resistance, R = 5 hPa(l/s)‐1 ± 10 %;
— compliance, C = 50 ml (hPa)‐1 ± 5 %;
b) how the alternative SUPPLY MAINS can be tested;
c) the behaviour of the VENTILATOR after a switch‐over to the INTERNAL ELECTRICAL POWER SOURCE or
alternative SUPPLY MAINS;
d) the behaviour of the VENTILATOR while the INTERNAL ELECTRICAL POWER SOURCE or alternative SUPPLY
MAINS is recharging.
Check compliance by functional testing and inspection of the instructions for use.
211.10.1.1 General requirements for mechanical strength
Amendment (add as the first paragraph):
The tests of IEC 60601‐1‐11:2015, Clause 10 and IEC 60601‐1:2005+AMD1:2012, 15.3 shall be
performed on the same test VENTILATOR after the cleaning and disinfection PROCEDURES of 201.11.6.6 of
this part of ISO 80601 have been performed unless there are no cleaning and disinfection PROCEDURES
specified in the instructions for use. If more than one PROCEDURE is specified in the instructions for use,
each PROCEDURE shall be so tested. A separate VENTILATOR may be used for each specified PROCEDURE.
Annexes of the general standard apply, except as follows.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Annex C
(informative)
Guide to marking and labelling requirements for ME EQUIPMENT and

ME SYSTEMS
201.C.1 Marking on the outside of ME EQUIPMENT, ME SYSTEMS, or their parts

Additional requirements for marking on the outside of a VENTILATOR, its parts, and ACCESSORIES are found
in Table 201.C.101.
Table 201.C.101 — Marking on the outside of a VENTILATOR, its parts or ACCESSORIES
Description of marking Subclause

Any particular storage and/or handling instructions 201.7.2.101 a)
Any particular warnings and/or precautions relevant to the immediate operation of 201.7.2.101 b)
the VENTILATOR
Arrow indicating the direction of the flow for FLOW‐DIRECTION‐SENSITIVE COMPONENTS, if 201.7.2.101 d)
applicable
Containing natural rubber latex, if applicable 201.7.2.13.101
For ACCESSORIES supplied separately, indication of any limitations or adverse effects of 201.7.2.4.101
the ACCESSORY on the BASIC SAFETY or ESSENTIAL PERFORMANCE of the VENTILATOR, if
applicable
For ACCESSORIES supplied separately, the requirements of 201.7.2.101, 201.7.2.13.101, 201.7.2.4.101
and 201.7.2.17.101
For each VBS part and ACCESSORY, contains phthalates, if applicable 201.11.6.4
For packaging, containing natural rubber latex, if applicable 201.7.2.17.101 c)
For packaging, description of the contents 201.7.2.17.101 a)
For packaging, identification reference to the batch, type, or serial number 201.7.2.17.101 b)
Gas name or chemical symbol for any gas‐specific inputs and outlets, if applicable 201.7.2.101 c)
Gas‐specific colour coding for any gas‐specific inputs and outlets, if applicable 201.7.2.101 c)
Legibility of controls or indicators 201.12.1
Mandatory action safety sign: follow instructions for use 201.7.2.3
Trigger sensitivity control minimum and maximum settings self‐evident, if applicable 201.7.4.2
Trigger sensitivity control not only numeric, if applicable 201.7.4.2
Warning not to obstruct the GAS INTAKE PORT, if applicable 201.7.2.101 e)
201.C.2 ACCOMPANYING DOCUMENTS, general

Additional requirements for general information to be included in the ACCOMPANYING DOCUMENTS of a
VENTILATOR or its parts are found in Table 201.C.102.

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ISO 80601-2-72:2015(E)
Table 201.C.102 — ACCOMPANYING DOCUMENTS, general
Description of requirement Subclause

Description of the means by which the obstruction ALARM CONDITION is determined 201.12.4.107
Description of the means by which the partial‐occlusion ALARM CONDITION is 201.12.4.108
determined, if provided
Description of the means to test the obstruction ALARM CONDITION 201.12.4.107
For each VBS and ACCESSORY, the MODEL OR TYPE REFERENCE of at least one compatible 201.102.2
VENTILATOR
For each VBS part and ACCESSORY, a statement to the effect that ventilator breathing 201.102.2 a)
systems, their parts, and accessories are validated for use with specific ventilators
For each VBS part and ACCESSORY, a statement to the effect that incompatible parts can 201.102.2 b)
result in degraded performance
For each VBS part and ACCESSORY, a statement to the effect that the responsible 201.102.2 c)
organization is accountable for the compatibility of the ventilator and all of the parts
and accessories used to connect to the patient before use
Maximum time‐weighted average input flow for each gas, if applicable 201.4.11.101.2 3) i)
Maximum transient input flow for each gas, if applicable 201.4.11.101.2 3) ii)
Name or trade name and address of the MANUFACTURER and where the MANUFACTURER 201.7.9.1
does not have an address within the locale an authorized representative
Units of measure for AIRWAY PRESSURE capable of being in hPa 201.7.4.3
Units of measure for volumes, flows, and leakages expressed as STPD or BTPS, as 201.7.4.3
appropriate
Warning that the VENTILATOR is a high flow device warning, if applicable 201.4.11.101.2 3) iii)
201.C.3 ACCOMPANYING DOCUMENTS, instructions for use

Additional requirements for information to be included in the instructions for use of a VENTILATOR or its
parts are found in Table 201.C.103.
Table 201.C.103 — Instructions for use

Accuracy of expired volume MONITORING EQUIPMENT, if so equipped 201.12.4.103
Accuracy of the DELIVERED VOLUME MONITORING EQUIPMENT 201.12.1.104
Alternative SUPPLY MAINS, maximum current required 201.11.8.101 d)
Alternative SUPPLY MAINS, means of connection 201.11.8.101 a)
Alternative SUPPLY MAINS, NOMINAL voltage range 201.11.8.101 c)
Alternative SUPPLY MAINS, RATED voltage range 201.11.8.101 b)
Any natural rubber latex‐containing components, if applicable 201.7.2.13.101
Any adverse effect of any recommended ACCESSORY on the BASIC SAFETY or 201.7.9.2.14.101 b)
ESSENTIAL PERFORMANCE of the VENTILATOR, if applicable
A‐weighted sound power level emitted by the VENTILATOR 201.9.6.2.101

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ISO 80601-2-72:2015(E)
Table 201.C.103 (continued)

A‐weighted sound pressure level emitted by the VENTILATOR 201.9.6.2.101
Behaviour of the VENTILATOR after a switchover to the INTERNAL ELECTRICAL POWER 211.8.4.101 c)
SOURCE or alternative SUPPLY MAINS
Behaviour of the VENTILATOR while the INTERNAL ELECTRICAL POWER SOURCE or 211.8.4.101 d)
external reserve electrical power source is recharging
Description of the INTERNAL ELECTRICAL POWER SOURCE care and maintenance 201.7.9.2.13 b)
PROCEDURES, including instructions for recharging or replacement, if applicable
Description of the periodic visual safety inspections that should be performed 201.7.9.2.13 a)
by the OPERATOR
Disclosure of any restrictions on the placing of components within the 201.7.9.2.14.101 a)
VENTILATOR BREATHING SYSTEM, if applicable
For a VENTILATOR intended for non‐invasive ventilation, a warning statement to 201.102.6.2

the effect that the exhaled volume of the PATIENT can differ from the measured
exhaled volume due to leaks around the MASK
For a VENTILATOR, an explanation of the meaning of the IP classification marked 201.7.9.2.9.101 b)
on the ME EQUIPMENT
For a VENTILATOR, its parts or ACCESSORIES intended for single‐use, information on 201.7.9.2.1.102 a)
known characteristics and technical factors known to the MANUFACTURER that
could pose a RISK if the VENTILATOR, its parts or ACCESSORIES would be re‐used
For a VENTILATOR, its parts or ACCESSORIES intended for single‐use, intended 201.7.9.2.1.102 b)
duration of use
For ACCESSORIES supplied separately where marking the ACCESSORY is not 201.7.2.4.101
practicable, the requirements of 201.7.2.4.101, 201.7.2.13.101, and
201.7.2.17.101
For each VBS, part and ACCESSORY, information on RESIDUAL RISKS for children or 201.11.6.4
treatment of pregnant or nursing women and, if applicable, on appropriate
precautionary measures for devices that contain phthalates
For the LAY OPERATOR instructions, a description of a means to determine the 201.7.9.2.9.101.1 f)
operation time of the INTERNAL ELECTRICAL POWER SOURCE
For the LAY OPERATOR instructions, a description of how the listed ALARM 201.7.9.2.9.101.1 d)
CONDITIONS can be tested
For the LAY OPERATOR instructions, a description of how the low oxygen ALARM 201.7.9.2.9.101.1 e)
CONDITION can be tested, if provided
For the LAY OPERATOR instructions, a description of how to connect a DISTRIBUTED 201.7.9.2.9.101.1 g)
ALARM SYSTEM
For the LAY OPERATOR instructions, an explanation of the meaning of the IP 201.7.9.2.9.101.1 b)
classification
For the LAY OPERATOR instructions, an indication as to whether the VENTILATOR is 201.7.9.2.9.101.1 c)
intended for non‐invasive ventilation
For the LAY OPERATOR instructions, conditions under which the VENTILATOR 201.7.9.2.9.101.1 a)
maintains the accuracy of controlled and displayed variables

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)

For the LAY OPERATOR instructions, method by which all of the ALARM SIGNALS, 201.7.9.2.8.101
including the ALARM SIGNALS from DISTRIBUTED ALARM SYSTEMS, can be functionally
tested to determine if they are operating correctly
For the LAY OPERATOR instructions, method by which all switchover to and 201.7.9.2.8.101
operation from the INTERNAL ELECTRICAL POWER SUPPLY can be functionally tested
to determine if they are operating correctly
For the LAY OPERATOR instructions, method by which the assembled breathing 201.7.9.2.8.101
tubes and related ACCESSORIES can be functionally tested to determine if they are
operating correctly
For the LAY OPERATOR instructions, the specifications of any ACCESSORIES or 201.7.9.2.8.101
equipment required to perform the tests described in 201.7.9.2.8.101
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 f)
instructions, a description of how the listed ALARM CONDITIONS can be tested
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 i)
instructions, a statement as to whether any portion of the gas supplied to a
HIGH‐PRESSURE INPUT PORT is supplied to the PATIENT, if applicable
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 e)

instructions, any limitation of parameter settings
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.8.101
instructions, method by which all functions and settings necessary for NORMAL
USE can be functionally tested to determine if they are operating correctly
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 g)

instructions, the essential technical characteristics of each recommended
BREATHING SYSTEM FILTER, if applicable
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.1.101

instructions for use, the information contained in the instructions for use for the
LAY OPERATOR
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 b)

instructions, the methods for controlling the cycling
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 c)
instructions, the parameter settings
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 d)
instructions, the range of parameter settings
instructions, the RATED range of compliance of the assembled OPERATOR‐
detachable parts of the VBS, over which the accuracies of set and monitored
volumes and pressures are maintained
instructions, the RATED range of inspiratory and expiratory gas pathway
resistances of the assembled OPERATOR‐detachable parts of the VBS, over which
the accuracies of set and monitored volumes and pressures are maintained
For the supervising clinician or the healthcare professional OPERATOR 201.7.9.2.9.101.2 a)
instructions, the working principle of each of the VENTILATOR’S ventilation modes
including waveforms

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)

Information on how to connect CO2 MONITORING EQUIPMENT, if not so equipped, if 201.12.4.104
applicable
Information on how to connect O2 MONITORING EQUIPMENT, unless such equipment 201.12.4.101
is an integral part of the VENTILATOR
Length of time between the loss of power and impending INTERNAL ELECTRICAL 211.8.4.101
POWER SOURCE failure warning ALARM CONDITION
Maximum error of the AIRWAY PRESSURE at the end of the inspiratory phase in 201.12.1.103
relation to the set value for a pressure‐controlled breath in NORMAL CONDITION
Maximum error of the AIRWAY PRESSURE at the end of the inspiratory phase in 201.12.1.103
relation to the set value for a pressure‐controlled breath in NORMAL CONDITION
under leak condition
Maximum error of the DELIVERED VOLUME in relation to the set value for a 201.12.1.102
volume‐controlled breath in NORMAL CONDITION
Maximum error of the inspiratory oxygen concentration (FiO2) at the PATIENT‐ 201.12.1.103
CONNECTION PORT in relation to the set value for a pressure‐controlled breath in
NORMAL CONDITION, if provided
Maximum error of the inspiratory oxygen concentration (FiO2) at the PATIENT‐ 201.12.1.102
CONNECTION PORT in relation to the set value for a volume‐controlled breath in
NORMAL CONDITION, if provided
Maximum error of the PEEP in relation to the set value for a pressure‐controlled 201.12.1.103
breath in NORMAL CONDITION
Maximum error of the PEEP in relation to the set value for a volume‐controlled 201.12.1.102
breath in NORMAL CONDITION
Means by which the alternative SUPPLY MAINS can be tested 211.8.4.101
Operational time of the power sources when fully charged 211.8.4.101 a)
Processing or reprocessing instructions for the VENTILATOR and its ACCESSORIES 201.11.6.6
Separate instructions for use for LAY OPERATOR 201.7.9.2.1.101
Separate instructions for use for supervising clinician or the healthcare 201.7.9.2.1.101
professional OPERATOR
Statement to the effect that the VENTILATOR is to be equipped with CO2 201.12.4.104
MONITORING EQUIPMENT before being put into service, if not so equipped, if
applicable
Statement to the effect that the VENTILATOR is to be equipped with O2 MONITORING 201.12.4.101
EQUIPMENT for the measurement of inspiratory oxygen concentration before
being put into service, if not so equipped
Summary description of the VENTILATOR algorithm for determining the AIRWAY 201.12.4.102
PRESSURE ALARM LIMIT, if provided
Summary description of the VENTILATOR algorithm for determining the DELIVERED 201.12.1.104
VOLUME ALARM LIMIT, if provided
Summary description of the VENTILATOR algorithm for determining the expired 201.12.4.103
volume ALARM LIMIT, if provided

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)

Warning statement to the effect to always have immediate access to an 201.7.9.2.2.101 c)
alternative means of ventilation to avoid patient death or serious injury
Warning statement to the effect to not add any attachments or accessories to 201.7.9.2.2.101 d)
the ventilator that are not listed in the instruction for use or the ventilator
might not function correctly
Warning statement to the effect to not connect the ventilator to the battery of a 201.7.9.2.2.101 g)
wheelchair battery‐powered wheelchair unless the connection is listed in the
instructions for use of the ventilator or wheelchair as this can affect the
ventilator performance which consequently can result in patient death
Warning statement to the effect to not cover the ventilator or place in a position 201.7.9.2.2.101 b)
that affects proper operation, including applicable examples
Warning statement to the effect to not use the ventilator at an altitude above 201.7.9.2.2.101 f)
(insert maximum RATED altitude) or outside a temperature of (insert RATED
temperature range). Using the ventilator outside of this temperature range or
above this altitude can affect the ventilator performance which can
consequently result in patient death
Warning statement to the effect that the ventilator accuracy can be adversely 201.7.9.2.2.101 j)
affected by the gas added by the use of a pneumatic nebuliser, if applicable
Warning statement to the effect that to prevent death or serious injury, monitor 201.7.9.2.2.101 a)
the patient and the ventilator regularly in order to determine the need to
provide emergency ventilation when an alarm sounds or the ventilator
malfunctions
Warning statement to the effect that to reduce the likelihood of disconnection 201.7.9.2.2.101 i)
and to prevent adverse ventilator performance, use only accessories compatible
with the ventilator. Compatibility is determined by reviewing the instructions
for use of either the ventilator or the accessories
Warning statement to the effect that unintentional leaks cause indicated volume 201.7.9.2.2.101 k)
and expired CO2 values to differ from actual patient values, if applicable
Warning statement to the effect that when using nebulisation or humidification, 201.7.9.2.2.101 e)
the breathing system filter will require more frequent replacement to prevent
increased resistance or blockage, if applicable
Warning statement to the effect that when using the ventilator in a carrying 201.7.9.2.2.101 h)
case, only use a carrying case that is listed in the instruction for use to prevent
adverse ventilator performance which can consequently result in patient death
Which portions of the gas pathways through the VENTILATOR can become 201.7.9.2.12
contaminated with body fluids or expired gases during both NORMAL CONDITION
and SINGLE FAULT CONDITION

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
201.C.4 ACCOMPANYING DOCUMENTS, technical description

Additional requirements for information to be included in the technical description of a VENTILATOR or
its parts are found in Table 201.C.104.
Table 201.C.104 — Technical description

Description of a method for checking the function of ALARM SYSTEM for ALARM 201.7.9.3.101
CONDITIONs of this part of ISO 80601, if not performed automatically at start‐up
Disclosure of the interdependence of control functions 201.7.9.3.1.101 b)

Disclosure of the uncertainty for each disclosed tolerance 201.5.101.3
Listing of which ALARM CONDITIONs are checked automatically at start‐up 201.7.9.3.101
Means of restricting access 201.109
Pneumatic diagram of the VENTILATOR, including a diagram for OPERATOR‐detachable 201.7.9.3.1.101 c)
parts of the VENTILATOR BREATHING SYSTEM either supplied or recommended in the
instructions for use
Statement to the effect that the responsible organization needs to ensure the 201.7.9.3.1.101 f)
compatibility of the ventilator and all of the parts and accessories intended to be used
to connect to the patient prior to use
Summary description of the detection algorithm for the continuing positive‐pressure 201.12.4.110
ALARM CONDITION
Summary description of the filtering and/or smoothing techniques for all measured 201.7.9.3.1.101 a)
and/or computed variables that are displayed or used for control
Summary description of the means by which the continuing pressure ALARM CONDITION 201.7.9.3.1.101 e)
is detected and a summary description of the detection algorithm
Summary description of the means of initiating and terminating the inspiratory 201.7.9.3.1.101 d)
phase while the VENTILATOR is operating in each of its ventilatory modes

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Annex D
(informative)
Symbols on marking
IEC 60601‐1:2005 and IEC 60601‐1:2005/AMD1:2012, Annex D applies, except as follows:

Addition:
Table 201.D.2.101 — Additional symbols on marking

No Symbol Reference Title
1 ISO 7000‐2492 Batch code
Symbol 5.1.5
ISO 15223‐1:2012
2 ISO 7000‐2493 Catalogue number
Symbol 5.1.6
ISO 15223‐1:2012
3 ISO 7000‐2498 Serial number

Symbol 5.1.7
ISO 15223‐1:2012
4 ISO 7000‐2725 Contains or presence
of natural rubber latex
Symbol 5.4.5
ISO 15223‐1:2012
NOTE EN 15986:2011 provides additional information for phthalate symbols.
Additional Annexes:

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Annex AA
(informative)
Particular guidance and rationale
AA.1 General guidance

This Annex provides a rationale for some requirements of this part of ISO 80601 and is intended for
those who are familiar with the subject of this part of ISO 80601 but who have not participated in its
development. An understanding of the rationales underlying these requirements is considered to be
essential for their proper application. Furthermore, as clinical practice and technology change, it is
believed that a rationale will facilitate any revision of this part of ISO 80601 necessitated by those
developments.
AA.2 Rationale for particular clauses and subclauses
The numbering of the following rationales corresponds to the numbering of the clauses in this part of
ISO 80601. The numbering is, therefore, not consecutive.
201.1.1 Scope
There are key contextual differences between a home VENTILATOR and a critical care VENTILATOR, even
for VENTILATOR‐dependent PATIENTS. One difference is the stability of the PATIENT. Another is the balance
between ventilation and other important lifestyle functions, such as eating, speaking, psychosocial
aspects, and general physical activity. When choosing and configuring modes, circuits, and ALARM
CONDITIONS, the supervising clinician and PATIENT need to balance (1) knowledge and certainty of
ventilation against (2) the PATIENT’S autonomy and lifestyle.
The definition of dependent PATIENT provided in this part of ISO 80601 correctly identifies that
dependent PATIENTS do not necessarily rely on the VENTILATOR for every breath. So for many home
PATIENTS, the support offered by a VENTILATOR can be intermittent or episodic and even when support is
provided, the degree of support can be highly variable. For example, for the chronically tracheotomised
PATIENT, the act of speech requires a deflated cuff and a variable leak to atmosphere. The cuff often
remains deflated throughout the day, and, in the case of volume target ventilation, the tidal volume is
arbitrarily increased to account for the variable lost volume. In this situation, monitoring of both
inspiratory and expiratory volume is likely to be an inaccurate representation of the respired volume.
However, it’s unlikely that the monitoring of expiratory flow is available anyway, because any benefit of
an expiratory limb is outweighed by its encumbrance. The monitoring of end‐tidal CO2 (etCO2) can also
be unreliable, particularly if there is any PEEP configured (PEEP in the presence of leak dilutes the
measurement and introduces variability). At night, the cuff can be inflated, requiring the tidal volume
setting to be altered to avoid over‐ventilation. An alternate example is intermittent mouthpiece
ventilation, where the VENTILATOR might not routinely sample the expired volume at all.
These very typical situations do not benefit from the expensive instrumentation essential for a
traditional VENTILATOR to comply with standards. For the tracheotomised PATIENT, relative accuracy can
be equally effective as absolute accuracy because the volume is adjusted arbitrarily more than half the
day. In fact, one ‘ideal’ strategy can be a robust leak estimation scheme that perfectly compensated for
the leak while present, and then decompensated once the leak is resolved. Which is the best home
VENTILATOR? Is the expense imposed by extra instrumentation justified? The answer is, it depends on
the PATIENT, the clinical adjustments, the VENTILATOR, and the quality of its labelling. Absolute accuracy
can be critical. Or it can be that the most robust safety measure is a simple apnoea ALARM CONDITION, or
independent monitoring, or a PATIENT prepared to take responsibility in return for autonomy.
Despite this nuanced reality involving a broad range of PATIENTS, this part of ISO 80601 draws heavily
from the traditional hospital VENTILATOR standards. It currently mandates the monitoring of inspiratory

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
volume expiratory volume, and/or etCO2, and places great emphasis on accuracy of ventilation target
(pressure or volume) and how this accuracy is maintained in the face of different circuit ACCESSORIES. It
mandates the same monitoring accuracy target as the critical care VENTILATOR standard, across all VBS
circuit configurations.
Does mandating the traditional VENTILATOR requirements serve the ventilated individual well? By doing
so, the choice of circuits and ACCESSORIES available to the supervising clinician and PATIENT can be
unnecessarily constrained. Does loosening the requirements serve the supervising
clinician/PATIENT/carer any better? It depends on the situation, and so it is a topic better managed by
RISK MANAGEMENT than mandatory requirements. For an autonomous dependent PATIENT, a life‐support
VENTILATOR with good relative volume accuracy can be entirely appropriate, with judicious
configuration of ALARM SETTINGS enabled by well written clinical instructions. The monitoring of
expiratory volume and etCO2 is unnecessary. By contrast, an extremely dependent PATIENT or one of
poor mentation can be routinely reliant on accurate monitoring, possibly independent from the
VENTILATOR. In short, the monitoring requirements should be commensurate with the fragility of the
PATIENT and their environment, and the labelling should advise accordingly.
201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE

ESSENTIAL PERFORMANCE as “ventilation within the ALARM LIMITS set by the OPERATOR or generation of an
ALARM CONDITION” is inclusive of those breaths that the PATIENT modifies outside of the ventilatory
parameters set by the OPERATOR, but still within the ALARM LIMITS that are considered safe by the
OPERATOR. It is expected that the OPERATOR sets appropriate ALARM LIMITS, which thereby define the
ESSENTIAL PERFORMANCE for a particular PATIENT.
For example, the modern life‐supporting VENTILATOR has differing modes of ventilation that can consist
of multiple breath types. This is necessary as PATIENT response to ventilation is unpredictable. PATIENT‐
initiated breaths or breaths where the inspiration is terminated by the PATIENT can have characteristics
that are different from those that have been set by the OPERATOR.
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT
Since much of the VBS is likely to be draped over or around the PATIENT, it is likely to come into direct
contact with the PATIENT during NORMAL USE. Additionally, the gas pathways conduct fluids into or out of
the PATIENT. As such, the gas pathways of the VBS and the VENTILATOR need to be investigated regarding
biocompatibility and compatibility with substances that might pass into the PATIENT via the gas
pathways. Also of concern are electrical HAZARDS should any circuitry be incorporated into the VBS. By
ensuring that those items are subject to the requirements for APPLIED PARTS, these issues are addressed
by the requirements already in the general standard.
201.4.10.2 SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS
For d.c. SUPPLY MAINS, the requirements support operation from lead‐acid batteries and automobiles. A
typical 12 V lead‐acid battery has an open circuit voltage of approximately 12,65 V when fully charged.
This voltage drops to approximately 12,06 V when 25 % charged. Furthermore, while cranking the
engine, automotive lead‐acid batteries are RATED for their ampacity while maintaining 7,2 V.
MANUFACTURERS need to consider whether or not their equipment needs to operate under this condition.
While the engine is running, the battery charging system typically maintains the .d.c. voltage between
12,8 V and 14,8 V.[20][22] The values for d.c. operation are also consistent with the European standard
medical devices carried in an air ambulance as described in EN 13718‐1:2008.[23]
201.4.11.101 Additional requirements for pressurized gas input
A VENTILATOR designed to be connected to a pressurized gas supply is required to continue to operate
reliably throughout its RATED range of supply pressures; and these pressures can only be maintained if
the VENTILATOR in NORMAL CONDITION does not attempt to draw more flow from the gas source than the
gas source is designed to supply. It is also expected that these VENTILATORS should be designed to
prevent an unacceptable RISK under possible SINGLE FAULT CONDITIONS of the pressurized gas supply.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Pressurized medical gas supplies, including MEDICAL GAS PIPELINE SYSTEMS and cylinder pressure
regulators conforming to current relevant standards, supply gas‐specific terminal outlets at a pressure
that is within an internationally agreed‐upon pressure range of 280 kPa to 600 kPa under NORMAL
CONDITION. It is expected that VENTILATORS should operate to their declared specification at any supply
pressure within this range.
In the case of a pressure regulator failure, the gas supply pressure could rise to the pressure regulator’s
supply pressure, which can be cylinder (tank) pressure. To safeguard against this or similar
eventualities, gas‐specific medical gas supply systems are required to be provided with a means to limit
their output pressure to not more than 1 000 kPa. All gas‐powered ME EQUIPMENT should be designed so
as not to present an unacceptable RISK if its supply pressure rises up to this value. There is a specific
requirement that VENTILATORS should continue operation with acceptable performance such that
PATIENTS can continue to be ventilated until such time as normal operation can be restored or that
alternative arrangements can be made.
VENTILATORS with maximum RATED input pressures exceeding 600 kPa are required to fulfil these
conditions at up to twice their maximum RATED input pressure.
Under the SINGLE FAULT CONDITION that the supply pressure of any one gas drops below 280 kPa, under
steady‐state conditions, it is understood that a VENTILATOR cannot be expected to continue to operate on
this gas. However, it is required that in this case, the VENTILATOR should detect the unacceptable low
pressure, produce an ALARM SIGNAL and also, in the case of two pressurized gas supplies, automatically
switch to use the other gas source (oxygen or air) to drive the VENTILATOR. This requirement is stated in
201.13.101.
To ensure that the minimum pressure of 280 kPa can be maintained in practice, MEDICAL GAS PIPELINE
SYSTEMS supplying compressed medical gases through gas‐specific terminal outlets are designed so that
they can maintain this pressure at the input of gas‐powered devices while supplying steady‐state flows
up to 60 l/min at a single outlet connected directly to the pipeline; account is taken of the pressure drop
in the pipeline supplying the outlet and the pressure drop, at 60 l/min, across the terminal unit and the
hose assembly connecting the device to the pipeline.
The MEDICAL GAS PIPELINE SYSTEM is also required to be capable of supplying sufficient gas that this flow
can be drawn from a predetermined number of adjacent terminal units simultaneously. The actual
number will have been determined during the design and installation of the MEDICAL GAS PIPELINE SYSTEM
by the application of a ‘diversity factor’; a factor agreed upon between the supplier and RESPONSIBLE
ORGANIZATION to be appropriate for each section of the installation according to the designated purpose
of each area supplied. Recommended diversity factors are formulated to ensure that the MEDICAL GAS
PIPELINE SYSTEM is capable of supplying an average flow of 60 l/min to the required proportion of
terminal outlets. However, if the flow demand from many adjacent VENTILATORS exceeds 60 l/min, there
is an increased possibility that the VENTILATOR input pressure could fall below 280 kPa, mainly because
of the increased pressure drop across the terminal unit and input hose assembly (also because of the
flow‐drop characteristic in the case of pressure regulators supplying a single terminal outlet).
In addition to steady‐state flows of 60 l/min, the switching of the internal pneumatic system and the
operation of a PATIENT demand system can result in a VENTILATOR requiring transient input flows far in
excess of 60 l/min. Because of the compressibility of gas at pipeline pressures and the diameter of
piping that is employed in order to minimize the pressure drop, such transient demands can generally
be accommodated from the gas contained locally within the pipe work of the MEDICAL GAS PIPELINE
SYSTEM. There can be temporary pressure drops of the input pressure at the inlet of the VENTILATOR to
below 280 kPa due to transient flows in excess of 200 l/min (over 3 s) but most of these drops will be
within the supply hose assemblies specified by the MANUFACTURER. MANUFACTURERS need to evaluate
their own designs to establish whether any consequent transient pressure drop affects the performance
of their VENTILATOR when used with recommended supply hose configurations and when connected to
alternative gas‐specific terminal outlets such as those fitted to cylinder pressure regulators conforming
to ISO 10524‐1.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
VENTILATORS that can draw greater average or transient flows during INTENDED USE are permitted, but
their ACCOMPANYING DOCUMENTS are required to disclose those flows and warn of the need for a different
diversity factor.
The average flow of 60 l/min is greater than the test flow used during the commissioning of MEDICAL GAS
PIPELINE SYSTEMS. In itself, this should be of no concern because the conditions specified for the test do
not allow a direct comparison between the two values. The subcommittee responsible for pipeline
standards, ISO/TC 121/SC 6, in consultation with ISO/TC 121/SC 1 and ISO/TC 121/SC 3, agreed to the
60 l/min average flow value, and also the 200 l/min for up to 3 s transient flows, during the preparation
of the first edition of the current series of standards for MEDICAL GAS PIPELINE SYSTEMS and were aware of
the need to satisfy that specification when finalizing the MEDICAL GAS PIPELINE SYSTEM test requirements.
MANUFACTURERS should be aware that other medical gas supply system standards permit the fitting of
gas‐specific terminal outlets to supply systems such as pendant supply units. Such subsystems restrict
the flow that can be drawn from their terminal outlets.
201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT
After due consideration, the committee decided that where this part of ISO 80601 specifies adjoining
ranges for variables as the basis for testing and the declaration of performance, the end values of both
ranges should be applicable to both ranges. This means that a MANUFACTURER is free to use a round‐
number end value (e.g. 300 ml) in specifications and is not forced to truncate artificially the declared
range in order to avoid having to also satisfy the test requirements of the adjacent range. This permits,
for example, one VENTILATOR to have a declared range DELIVERED VOLUME of 300 ml to 1 000 ml and
another 100 ml to 300 ml, with each VENTILATOR only being required to be tested for the conditions
specified for ≥300 ml or ≤300 ml, respectively.
201.5.101.2 Gas flow rate and leakage specifications
Quantities of gas are frequently expressed as the volume that the gas occupies at standardized
conditions. Generally, one atmosphere (101,3 kPa) is used as standard pressure. However, several
standard temperatures are used. Whereas 0 °C is used as standard temperature in physics, either 20 °C
or 21,2 °C (70 °F) is often used in engineering. In ventilation, the gas in the lungs has a temperature
identical to body temperature (approximately 37 °C) irrespective of the temperature of the gas
delivered by a VENTILATOR. The volume of a given amount of gas increases by about 13,5 % from 0 °C to
37 °C or by 5,8 % from 20 °C to 37 °C.
Gas delivery systems supplying pressurized gas to medical equipment, including VENTILATORS, follow
engineering conventions and specify gas quantities and flow rates at STPD conditions. This practice is
followed in this part of ISO 80601 for all requirements concerning gas input.
However, VENTILATORS complying with this part of ISO 80601 are likely to be inflating the PATIENT’S
lungs relative to a local atmospheric pressure between 70 kPa and 110 kPa. In addition, the gas in the
lungs is always saturated with water vapour regardless of the humidity of the gas delivered from the
VENTILATOR. With a standard temperature of 0 °C, 1 l of gas referenced to standard temperature
pressure dry (STPD) can expand the lungs by 1,8 l at a pressure of 70 kPa. In order to have the values
comparable among different VENTILATORS, it is essential that the information for all VENTILATORS is
referenced to the same standard conditions. Because it is the volume of gas and not the number of
molecules that expands the lungs, BTPS is the appropriate set of reference conditions to use.
In VENTILATORS, a variety of flow transducers are used. Whereas a heated‐wire anemometer measures
the rate of mass flow of the gas independent of pressure, a pneumotachograph measures the flow of gas
at the actual pressure. Therefore, the necessary corrections depend on the type of flow transducer.
When a pressure correction is required, this can be adequately estimated.
The necessary corrections also depend on the location of the flow transducer in the VBS. The humidity of
the gas can be zero when the transducer measures the inspiratory flow inside the VENTILATOR. However,
when the flow transducer is located at the Y‐piece, the relative humidity can be anything up to 100 %.

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
When an HME is used for humidification, the output of the flow‐transducer depends on whether it is
located distal or proximal to the HME. With a blower‐based VENTILATOR that uses ambient air, the
humidity of the drawn‐in air can be unknown to the VENTILATOR. All these effects together inevitably
introduce some errors in the conversion of the measured flow signal to BTPS reference conditions.
However, these errors are only in the range of several percent. However, it remains the responsibility of
the MANUFACTURER to VERIFY that the accuracy requirements of 201.12.1, 201.12.4.102, and 201.12.4.103
are met.
201.5.101.3 VENTILATOR testing errors
When testing VENTILATOR performance, several of the test parameters cannot be measured without a
significant degree of measurement uncertainty due to limitations of the accuracy that can be achieved,
particularly when measuring volumes by the integration of rapidly changing flows.
Because of the relative significance of these uncertainties, it is important that MANUFACTURERS allow for
them when declaring parameter accuracy.
Similarly, it is important for a third‐party tester to recognize the significance of the uncertainty in their
own measurements when testing to this part of ISO 80601.
In practice, this means that, for example, if a MANUFACTURER determines that a parameter has a tolerance
of ±7 % but that the measurement uncertainty is ±3 %, then a parameter tolerance of ±10 % is declared.
If a third‐party tester subsequently obtains an error of the measured value for that parameter of ±15 %
with a measurement uncertainty of ±5 %, then the third‐party tester has to accept the MANUFACTURER’S
claim.
Furthermore, the MANUFACTURER is required to disclose the measurement uncertainty for each declared
value in order to provide both information to the RESPONSIBLE ORGANIZATION and guidance for a third‐
party tester as to the needed measurement accuracy when testing to this part of ISO 80601.
201.7.2.3 Consult ACCOMPANYING DOCUMENTS
The committee agreed that following the instructions for use is a mandatory action for the safe
operation of a VENTILATOR.
201.7.4.3 Units of measurement
Additional information is found in rationale for 201.5.101.2.
201.7.9.2.2.101 Additional requirements for warnings and safety notices
d)
The OPERATOR should be aware that only the parts or ACCESSORIES listed in the instruction for use have
been validated by the MANUFACTURER. The use of non‐validated parts can represent an unacceptable RISK.
EXAMPLE 1 A power supply unit other than the one recommended by the MANUFACTURER might be designed
and manufactured with poor quality (bad reliability), might affect the electromagnetic compatibility of the
VENTILATOR, etc.
EXAMPLE 2 The connection of parts to the VBS that are not listed in the instruction for use can increase the
inspiratory or expiratory pathway resistance of the VBS, can increase the unintentional leakage of the VBS, etc. to a
level that will affect the BASIC SAFETY and ESSENTIAL PERFORMANCE.
e)
The functionality of BREATHING SYSTEM FILTERS is affected by a number of aspects of structure, properties,
and local environment.
At the most basic, a BSF is designed to be a filter that removes particles suspended in gas, i.e. a “dry
aerosol”. The particles primarily targeted in the VBS are bacteria or virus particles (although other
particles would be subject to retention). The filtering material (“medium”) is composed of a matrix of

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ISO 80601-2-72:2015(E)
solid material with open passageways to allow gas flow. The passageways in such gas filters are
relatively large compared to the bacteria and virus particles that are to be removed. The spatial
arrangement of the solid part of the filter medium versus the open spaces in the medium brings the
particles in proximity to the surfaces of the medium, where physical forces (electrostatic attraction and
Van der Waals forces) attract and bind the particles within the matrix, removing them from the gas
flow.
In the practical situation of anaesthesia or respiratory care therapy, environmental factors related to
the PATIENT or the therapy can alter the performance of the BSF from that which would occur in the
simple flow of air with suspended microorganisms though the BSF.
One major factor is the presence, phase, and amount of moisture present in the gas flowing through the
BSF.
When there is low humidity in the gas (gaseous phase moisture), the gaseous water molecules generally
pass though the filter medium without effect. If there is a sufficiently high relative humidity, some BSFs
can adsorb or absorb part of this humidity.
If the moisture exists as a liquid aerosol, the water droplets can also be retained by the filter.
The property of a filter medium that governs the degree to which this interaction with water takes place
is its relative affinity for water. A medium which readily attracts water is termed “hydrophilic” and a
medium which repels water is termed “hydrophobic”. These properties are, in fact, not discrete, but
exist on a continuous scale. Nevertheless, in common parlance filters are grouped into being (relatively)
hydrophilic or hydrophobic.
Another example of liquid phase water can be termed “bulk water”. An example of this is the collected
condensate that occurs in the expiratory limb of the VBS. Depending on the management of the circuit
and the positioning of the BSF, this bulk water can actually completely cover and occlude the filter. If a
sufficient pressure is applied, the liquid water can be forced though the pores of the filter medium. This
requires relatively low pressure for a hydrophilic filter and relatively high pressure for a hydrophobic
filter.
The practical consequences of the latter scenario is that if liquid is forced though a hydrophilic BSF, gas
flow blockage can be relieved, but any microorganisms removed by the filter can be carried past the
filter with the liquid stream. In the case of a hydrophobic filter, the pressure in the VBS is usually not
sufficient to force liquid though the medium, so the microbial retention is not compromised. Airflow
occlusion persists, however, until steps are taken to remove the bulk water.
In addition, there can be a temporal aspect to the properties of relative hydrophilicity or
hydrophobicity; whereby prolonged exposure to water alters these properties during the EXPECTED
SERVICE LIFE of the BSF. A BSF is typically labelled with an EXPECTED SERVICE LIFE, in hours or days, that
reflects its ability to perform to its labelled specifications in the clinical environment.
It should be obvious that the potential influence of water on performance differs in anaesthesia and
respiratory care applications, although many, if not most, BSFs are indicated for use in both applications.
Additional effects on BSF functionality can be caused by the introduction of substances other than water
or gas into the device. Such substances can originate from the PATIENT (e.g. sputum, exudates, blood,
vomitus) or substances introduced by the OPERATOR into the VBS (e.g. gross amounts of medications
intended to be nebulised for administration though the VBS).
The effect of such substances can be an increase in flow resistance of varying degree up to complete
occlusion at VENTILATOR or physiologic pressures. In the case of nebulised medications, the type of
nebuliser and its operating parameters are variables that affect the likelihood or magnitude of
significantly increased BSF flow resistance during a prescribed medication regimen. It should be
mentioned that accidental introduction of gross amounts of medication from the nebuliser reservoir
during OPERATOR or PATIENT manipulation of the VBS has been implicated as a source of acute BSF
blockage.

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ISO 80601-2-72:2015(E)
The cause of increased flow resistance in a BSF can be gross blockage of the medium passages or the
effects of surfactant properties of the substances introduced into the BSF upon the hydrophobicity of the
filter medium. It should be noted that medications indicated for nebulisation can contain surfactant
materials that are not identified in the medications’ labelling with respect to their presence or their
quantity, and these can change without notice for a given medication. The effect of these substances
upon flow resistance differs among individual models and brands of BSFs.
The OPERATOR needs to be aware that the effects of such substances can be manifested as increases in
the amount of positive AIRWAY PRESSURE required for a VENTILATOR‐provided breath, or as an increase in
expiratory flow resistance, resulting in a step‐wise increase in intrapulmonary pressure that, if not
detected, can lead to pneumothorax.
Awareness of the possibility, albeit infrequent or rare, of such significant increases in BSF flow
resistance and inclusion in a trouble‐shooting scheme for this and other causes of impaired ventilation
can reduce or eliminate adverse events occurring secondary to BSF flow occlusion.
Direct PATIENT monitoring and usage of the appropriate settings for, and prompt attention to,
VENTILATOR ALARM CONDITIONS are essential to provide maximum PATIENT safety.
Once a BSF is recognized to be a source of impaired ventilation, simply removing the occluded BSF and
replacing it with another BSF returns ventilation to a normal state.
g)
Wheelchair batteries, even though they mostly convey the appearance that they supply standard
voltages for auxiliary battery‐powered equipment, often provide neither the appropriate connector nor
an adequate voltage range to safely supply the VENTILATOR for normal operation. Depending on the
battery load condition required for the movement of the wheelchair, the voltages supplied at the
auxiliary connector often show major voltage drops and simultaneous current limitations. It is
reasonably foreseeable that these variations are often outside the external SUPPLY MAINS ratings of the
VENTILATOR. These might adversely affect the performance of the VENTILATOR or, in the extreme, these
voltage fluctuations might lead to a stoppage of ventilation. In addition, these SUPPLY MAINS variations
can also affect the electromagnetic compatibility of the VENTILATOR.
The OPERATOR needs to be aware that only wheelchairs listed in the instruction for use have been
validated by the MANUFACTURER. The use of non‐validated wheelchairs can represent an unacceptable
RISK for the PATIENT.
201.7.9.2.8.101 Additional requirements for start-up PROCEDURE

In some designs, adequate checking of the ALARM SYSTEM can be performed with a combination of
OPERATOR action and the power‐on self‐test routines that VERIFY the integrity of the software and the
integrity of the computer controlling the VENTILATOR, as well as the measuring sensors and the ALARM
SIGNAL generation.
201.7.9.2.9.101 Additional requirements for operating instructions

Some VENTILATORS are designed so that they can operate with higher‐than‐normal tubing circuit
compliance and resistance. Thus, knowledge of these VBS characteristics is important for the OPERATOR
to be aware of the VENTILATOR capability. Also, knowledge of the maximum VBS resistance (at NOMINAL
and maximum flowrates) is important because an occlusion FALSE POSITIVE ALARM CONDITION can be
caused by the use of high resistance components in the VBS. These characteristics of the VBS need to be
inclusive of any inhalation and exhalation particle/bacteria filters, HUMIDIFIER, nebuliser, water
collection vessels, and connectors needed for operation.
201.7.9.2.9.101.1 LAY OPERATOR operating instructions
d)
This part of ISO 80601 requires that instructions for use for both the LAY OPERATOR and the supervising
clinician or healthcare professional describe methods of testing VENTILATOR ALARM CONDITIONS. It is

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ISO 80601-2-72:2015(E)
useless to require these tests unless the tests serve the intended purpose of ensuring that OPERATORS are
alerted to potentially HAZARDOUS SITUATIONS while ventilating in the environment of use.
ALARM CONDITION testing instructions for the LAY OPERATOR need to provide simple tasks that create
ALARM LIMIT violations without changing any VENTILATOR settings.
LAY OPERATORS have a need to know that the ALARM LIMITS are likely to be violated when common but
potentially harmful situations occur. Since LAY OPERATORS might not be allowed to change VENTILATOR
settings, it is vitally important that they learn how to test a VENTILATOR while it is set up with prescribed
settings to determine that ALARM LIMITS are violated during interruption of ventilation (due to
disconnection, occlusion, etc.) and other potentially HAZARDOUS SITUATIONS.
ALARM CONDITION testing instructions for LAY OPERATORS are similar to reverse troubleshooting. A series
of simple tasks simulate problems and the OPERATOR verifies that the ALARM LIMITS intended to alert for
each problem are violated. It is best if these simulations can be performed without a test lung. For
improved LAY OPERATOR confidence, the healthcare professional might find it beneficial to demonstrate
these tests for the LAY OPERATOR.
For this type of VENTILATOR, ALARM CONDITION testing instructions for healthcare professional OPERATORS
should be as simple as possible, since it is intended that these VENTILATORS are used outside of a hospital
setting. These tests can require that the OPERATOR make settings changes and use a test lung in order to
test whether the VENTILATOR ALARM SYSTEMS are fully functional.
201.7.9.2.9.101.1 Supervising clinician operating instructions
f)
See rationale for 201.7.9.2.9.101.1 d).
201.7.9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used
material
The use of antistatic and/or electrically conductive materials in the VBS is not considered as
contributing to any higher degree of safety. On the contrary, the use of such material increases the RISK
of electrical shock to the PATIENT.
The MANUFACTURER is expected to express the description of the VENTILATOR in general terms so the
reader can understand the important behaviour of the VENTILATOR (e.g. mean values and their time
specifications, number of breaths, and delays etc.). Some items (e.g. pressures) that one would find in
the instructions for use of a professional use VENTILATOR are placed in the technical description for this
home use VENTILATOR as that information is not expected to be meaningful to the LAY OPERATOR, but is
necessary for the supervising clinician or the healthcare professional OPERATOR.
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT
The objective of this requirement is to protect the PATIENT from skin burns due to contact with the
external surface of the BREATHING TUBE.
The human airway has a very significant ability to absorb or deliver heat and moisture. Reference the
common practice of sitting in a sauna without HARM to the respiratory track.[37] Fully saturated gas at
45 °C can be inspired for up to 1 h without damaging the mucosa of the respiratory tract.[28] A more
recent study reported tolerance of inspired gas temperatures of 46,9 °C to 49,3 °C, 100 % RH
(265,6 kJ/kg) for 45 min[32].
Taking into account the enthalpy of inspired gas that has been shown to be tolerated without causing
thermal injury to the human airways and the very short exposure times of thermal overshoot from a
heated HUMIDIFIER in clinical practice, the delivered gas energy limit of 197 kJ/ m3 of dry gas when
averaged over 120 s can be used.

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ISO 80601-2-72:2015(E)
When considering gas mixtures other than oxygen/air, the following should be observed. Given that
most of the energy is contained in the water vapour, the equivalent of air at 43 °C, 100 % RH is the
maximum enthalpy that should be allowed. This has a specific volume of 0,9786 m3/kg of dry air and an
enthalpy content of 197 kJ/m3 of dry air. Assuming the volume breathed by the PATIENT is the same
whatever gas mixture is used, then the safe enthalpy limit is 197 kJ/m3 of dry gas. This enthalpy per
unit volume gives a more relevant measure of the energy delivered to the PATIENT.
Studies to measure the relative importance of exposure time and temperature in causing cutaneous
burns determined that surface temperatures of at least 44 °C and 6 h exposure were required to cause
irreversible damage to epidermal cells.[43] This is confirmed by studies conducted by the U.S. Navy
Medical Research and Development Command[28] which concluded that fully saturated gas at 45 °C can
be inspired for up to 1 h without damaging the mucosa of the respiratory tract.
Gas at body temperature and fully saturated (37 °C and 100 % RH) does not transfer thermal energy to
or from the PATIENT with a normal body temperature of 37 °C. Dry gas at body temperature (37 °C and
0 % RH) draws heat away through evaporation. Gas at 41 °C and fully saturated has the capacity to
deliver less than 130 kJ/kg of dry gas breathed by the PATIENT.
201.11.6.6 Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM
The essential principles of ISO/TR 16142 require that medical devices are not to be operated or used if
their condition could compromise the health and safety of the PATIENT on whom they are being used or
the employees or third parties interacting with them.
This means that VENTILATORS, their ACCESSORIES, and parts cannot be used if there is a potential RISK of
the PATIENT, OPERATOR, or other person being infected as a result of contact with the VENTILATOR,
ACCESSORY, or part.
Therefore, VENTILATORS, their ACCESSORIES, and parts require an appropriate level of disinfection
depending on their use, but rarely need to be sterile.
Recommendations for hygienic reprocessing of VENTILATORS, their ACCESSORIES, and parts are based on
the general hygiene requirements for the reprocessing of medical devices and need to take into
consideration the special requirements and needs of PATIENT care in the clinical environment.[9] The
requirements for hygienic reprocessing of this part of ISO 80601 are intended to
— make the RESPONSIBLE ORGANIZATION for reprocessing the VENTILATOR aware of how to implement
these tasks in a responsible manner through appropriate delegation, and
— help all parties involved in the reprocessing of VENTILATORS, their ACCESSORIES, and parts to comply
with the MANUFACTURER’S instructions.
The cleaning and disinfection PROCEDURES of the MANUFACTURER are also intended to provide practical
support to all those involved in PATIENT care in the clinical environment with regards to implementing
the hygiene measures required for the PATIENT’S safety.
It should be noted that VENTILATORS, as all other medical devices that have been contaminated with
human pathogenic microorganisms, are a potential source of infection for humans. Any VENTILATOR that
has already been used on another PATIENT is potentially contaminated with contagious pathogenic
microorganisms until proven otherwise. Appropriate handling and reprocessing PROCEDURES are
essential to protect the next person handling the device or the next PATIENT on whom the device is used.
Hence, VENTILATORS, their re‐usable ACCESSORIES and parts that have been used are required to undergo a
reprocessing PROCESS, following the MANUFACTURER’S instructions, prior to reuse by another PATIENT.
The following basic considerations need to be addressed by the MANUFACTURER when specifying the
reprocessing instructions of a VENTILATOR, its ACCESSORIES or parts:
— protecting the PATIENT, the OPERATOR, and the RESPONSIBLE ORGANIZATION (including personnel
involved in performing the reprocessing PROCESS);

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ISO 80601-2-72:2015(E)
— the limits of the PROCEDURES used for reprocessing (such as the number of reprocessing cycles);
— the necessity to guarantee the proven standardised PROCEDURES to a consistently high and verifiable
quality, based on an established quality management system.
The recommended reprocessing PROCESS should be determined by the following:

— the potential degree and type of contamination of the VENTILATOR, ACCESSORIES or parts;
— the RISK of infecting another PATIENT resulting from their reuse and the type of application of the
VENTILATOR.
Special consideration of the possible RISK associated with the contamination of gas‐conducting
components due to the PATIENT’S re‐breathing under SINGLE FAULT CONDITION should be considered.
On the basis of the above, a VERIFIED and VALIDATED documented reprocessing PROCEDURE needs to be
specified in such detail so that the outcome is reproducible. An acceptable RESIDUAL RISK from the
HAZARD of infection for the next PATIENT can be assumed if the following conditions have been fulfilled:
— documented reprocessing PROCEDURE’S effectiveness has been VERIFIED through appropriate

scientific methods by the MANUFACTURER;
— reliability of the documented reprocessing PROCEDURES has been VERIFIED in practice through
appropriate quality assurance measures by the RESPONSIBLE ORGANIZATION carrying out the
reprocessing PROCEDURES.
When selecting and evaluating the reprocessing PROCEDURES, the MANUFACTURER should consider the
following:
— the amount and type of pathogenic microorganisms expected to contaminate the VENTILATOR,
ACCESSORIES, or parts;
— the RISK for the pathogenic microorganisms to be transmitted to the PATIENT, OPERATOR, or other
persons;
— the microorganism's resistance to the recommended reprocessing PROCEDURES.
The RISKS posed by a reprocessed VENTILATOR, ACCESSORIES, or parts are determined by the following
factors:
a) undesired effects, which can result from the following:
— previous use;
— previous reprocessing PROCESSES;
— transportation and storage;
b) the RISKS from subsequent uses, such as the following:
— residues from the previous use (such as secretions, other body fluids, and drugs);
— residues from the previous reprocessing PROCESSES (such as cleaning agents, disinfectants and
other substances, including their reaction products);
— changes of physical, chemical, or functional properties of the device;

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ISO 80601-2-72:2015(E)
— changes in the condition of the material (such as accelerated wear and tear, embrittlement and
changed surface conditions, connectors and adhesive joints);
c) the RISK of transmission of any pathogenic microorganisms.
When considering the suitability of the reprocessing PROCESS and the feasibility of the reprocessing
PROCESS for the VENTILATOR, ACCESSORIES, or parts, the MANUFACTURER should consider the following
points:
— RISKS involved in the reprocessing PROCESS;
— cost effectiveness of the reprocessing PROCESS;
— practicability of the reprocessing PROCESS;
— availability of the cleaning equipment and the cleaning agents specified in the reprocessing PROCESS;
— efficiency of the reprocessing PROCESS;
— reproducibility of the reprocessing PROCESS;
— quality management requirements of the reprocessing PROCESS;
— environmental impact of the reprocessing PROCESS and the disposal of the VENTILATOR, ACCESSORIES,
or parts.
The MANUFACTURER should VERIFY all cleaning agents and reprocessing PROCEDURES used with regard to
their suitability and repeatability with the VENTILATOR, ACCESSORIES, or parts, depending on the type of
use.
The RESPONSIBLE ORGANIZATION should VERIFY that manual cleaning and disinfection of the VENTILATOR,
ACCESSORIES, or parts are always carried out in accordance with the PROCEDURES specified in the
ACCOMPANYING DOCUMENT.
The MANUFACTURER should specify VALIDATED automated cleaning and disinfection PROCEDURES. If they
are not followed, the effectiveness of the cleaning and disinfection cannot be guaranteed. Such
parameters could include the volume of water used, water pressure, temperature, pH, dosage of
cleaning agents and disinfectants, and residence time.
To ensure the reproducibility of automated reprocessing PROCEDURES, tests should be carried out on a
regular basis.
The MANUFACTURER should ensure that the specified disinfection PROCEDURES are VERIFIED to be
bactericidal, fungicidal, and virucidal so that the cleaned and disinfected VENTILATOR, ACCESSORIES, or
parts do not pose an unacceptable RISK of infection by reproductive pathogenic microorganisms when
any of these elements, collectively or individually, comes in contact with the next PATIENT, OPERATOR, or
person.
Effective disinfection requires that the instructions for the disinfectant, especially with regards to
concentration and residence time, are followed.
Following any reprocessing PROCEDURE, a safety and functional testing of the VENTILATOR (as specified by
the MANUFACTURER’S instructions) needs to be carried out. If necessary, safety‐relevant functional testing
can be carried out directly before use of the VENTILATOR.
The extent and type of the tests depends on the VENTILATOR, ACCESSORY, or part and these need to be
defined in the ACCOMPANYING DOCUMENT.

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ISO 80601-2-72:2015(E)
201.12 Accuracy of controls and instruments and protection against hazardous outputs
The committee considered that the accuracy of set and displayed values is a key component of the
ESSENTIAL PERFORMANCE of a VENTILATOR (i.e. the delivery of ventilation at the PATIENT‐CONNECTION PORT
within the ALARM LIMITS set by the OPERATOR or generation of an ALARM CONDITION). The general standard
requires MANUFACTURERS to declare accuracies and to address the associated RISKS in the RISK
MANAGEMENT PROCESS. One of the associated RISKS is lack of consistency between MANUFACTURERS in their
declarations of accuracy, both in terms of the reference settings used and the conditions of test.
Consistency in these situations can only be achieved by means of internationally agreed standards and
these requirements have been formulated in order to fulfil this objective.
The test settings and conditions and, for certain parameters, minimum requirements, specified in this
subclause have been selected by the committee as those necessary to demonstrate adequate ESSENTIAL
PERFORMANCE of a VENTILATOR with regards to the parameters specified. The test PROCEDURES have been
written as TYPE TESTS (additional information is found in 3.135 and Clause 5), with the expectation that
MANUFACTURERS design their own test programmes to ensure that their declared accuracy tolerances for
the settings and conditions specified encompass any results obtained by a TYPE TEST performed in
accordance with the test PROCEDURES specified in this subclause.
201.12.1.104 DELIVERED VOLUME MONITORING EQUIPMENT
Evidence is accumulating that both volutrauma and barotrauma can result in respiratory morbidity and
affect long‐term respiratory outcome. Overstretching of the lung results in a decrease of the compliance
in the respiratory system, an increase in the water content of the lungs, and microscopic evidence of
alveolar and interstitial oedema, alveolar haemorrhage, and neutrophil infiltration.[41] The immature
lung is especially vulnerable to injury due to overstretching of the lungs.[43] Volutrauma has been
characterized by airway modelling and airway hyper‐responsiveness in infant rats.[42] In addition, the
early onset of airway hyper‐responsiveness is a predictor of bronchopulmonary dysplasia in human
infants,[43] a condition resulting in permanent lung injury.[45] As a result, the OPERATOR needs to know
both the DELIVERED VOLUME and AIRWAY PRESSURE to be able to assess the adequacy of the PATIENT'S
ventilation.
As with the measurement of AIRWAY PRESSURE, the site of the volume measurement is not specified, but
the value is required to be referenced to the PATIENT‐CONNECTION PORT (additional information is also
found in the rationale for 201.12.4.102). The permissible errors in both setting and measurement of
AIRWAY PRESSURE and DELIVERED VOLUME are reasonable for PATIENTS that require more than 50 ml
DELIVERED VOLUME, i.e. there is little RISK of over‐ventilating or under‐ventilating such PATIENTS. This is
less true for smaller PATIENTS, particularly those requiring tidal volumes of less than 50 ml, with stiff
lungs in volume‐control modes. As a result, MANUFACTURERS of VENTILATORS intended to deliver tidal
volumes of less than 50 ml should recommend the initial use of a pressure‐control ventilation mode
until such time as the cardiorespiratory status of the PATIENT has stabilized. Whether volume‐control
ventilation or pressure‐control ventilation is chosen is less the issue than is the maintenance of non‐
injurious tidal volumes as a function of body weight (usually predicted body weight or ideal body
weight). Although slightly lower than the range for paediatric and adult PATIENTS, the clinically accepted
value for infants lies in the range of 4 ml/kg to 6 ml/kg.
With a non‐leaking airway interface such as a cuffed tracheostomy tube, the monitoring of expired
volume is preferred as this provides a more accurate estimate of the pulmonary tidal volume. It is
confusing to the OPERATOR to have multiple ALARM CONDITIONS based on both DELIVERED VOLUME and
expired volume, and it is therefore appropriate that the monitoring of DELIVERED VOLUME and its
associated ALARM CONDITIONS be capable of being disabled when the monitoring of expired volume is in
use.
Airway interfaces which allow considerable gas leak are in common use. These include tracheostomy
tubes used without, or with an under‐inflated, cuff; tracheostomy tubes that incorporate a speech valve
(such as Passy‐Muir valve); and non‐invasive MASKS. In these use situations, the monitoring of expired
volume is impracticable and the committee believes that it is imperative that the DELIVERED VOLUME

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ISO 80601-2-72:2015(E)
monitor remain in use for maintaining PATIENT safety when the monitoring of expired volume is not in
use.
201.12.4.102 Measurement of AIRWAY PRESSURE
Additional information is also found in the rationale for 201.12.1.103.
The site in the VBS at which pressure is sensed varies from VENTILATOR to VENTILATOR. Generally, the
MANUFACTURER chooses one of the following two strategies:
— measuring the AIRWAY PRESSURE by direct sampling at the PATIENT‐CONNECTION PORT;
— indirectly estimating the pressure at the PATIENT‐CONNECTION PORT by measuring the pressures at
two locations in the VENTILATOR: on the inspiratory side of the VBS (at the “to PATIENT” port) and on
the expiratory side of the VBS (at the “from PATIENT” port), and, after mathematical manipulation,
averaging the two values.
201.12.4.103 Measurement of expired volume and low-volume ALARM CONDITIONS

It is desirable to have a fast‐responding measurement of volume and narrow ALARM LIMITS. However, as
there is often considerable variation in a PATIENT’S ventilatory pressures and volumes, narrow ALARM
LIMITS inevitably lead to clinically insignificant ALARM CONDITIONS. As a result, OPERATORS choose to set
wide ALARM LIMITS to reduce the number of insignificant ALARM CONDITIONS despite the fact that this can
compromise PATIENT care when there is a prolonged small change in ventilation. Therefore, it is
recommended that a VENTILATOR be designed to use initially a lower priority ALARM CONDITION, which
escalates to a higher priority if the ALARM LIMIT violation persists. The initial ALARM CONDITION priority
and the priorities and timing of the escalation should be determined by the severity of the potential
HARM to the PATIENT in combination with the length of time that the OPERATOR has to prevent the HARM
from occurring.
When the tracheostomy tube cuff is deflated during mechanical ventilation exhaled volume monitoring
is unreliable at best and likely impossible, especially when a speaking valve 9 is used in conjunction
with the deflated cuff. In spite of the impact on exhaled volume monitoring and the associated ALARM
CONDITIONS, there are several reasons why it can be preferable to deflate the tracheostomy tube cuff in
stable, mechanically ventilated PATIENTS. These quality‐of‐life reasons to deflate a tracheostomy tube
cuff of a ventilated PATIENT are outlined below.
Speech: When the tracheostomy tube cuff is deflated, it allows the PATIENT to exhale through the vocal
cords and communicate through speech. This is particularly important for children. Introducing the
speaking valve as soon as possible after tracheotomy offers more normal speech/language
development as the child is able to vocalize (e.g. cry, laugh, coo, and babble) which is an important
precursor to speech and is important to the parent/child bonding process.
Swallowing food and liquids (including secretions): Deflating the cuff allows the larynx to elevate
and move with anterior, natural mechanical motion each time one swallows that keeps the airway
safe from food and drink. The larynx is an organ of swallow and closed position speaking valves
restore positive subglottic pressure generated during the swallow. That positive pressure happens
as the lungs recoil during the apnoeic phase of the swallow against closed cords. The pressure
builds as high as 10 cmH2O, and is responsible for preventing food or drink from entering the
trachea, and stimulating vocal cord closure. When the larynx pulls forward during the swallow, it
pulls open the oesophagus; as the oesophagus opens, pressure falls (Boyle’s law) and a vacuum
environment is created to pull food or drink into the oesophagus, not through cords that have
positive pressure under them.
9 An example speaking valve is commercially available from Passy‐Muir, Inc., http://www.passy‐muir.com/. This information
is given for the convenience of users of this document and does not constitute an endorsement by ISO or IEC of this product.

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ISO 80601-2-72:2015(E)
Sensation/protection from aspiration: Redirecting exhaled air through the oropharynx restores
sensation and allows the PATIENT to feel the back of his throat. If a cuff is inflated, sensation is dulled
and the PATIENT is at a higher RISK of aspiration because the cuff is inflated. Oral secretions do not
pool in the back of the throat because sensation is restored and the PATIENT coughs, clears, and/or
swallows those secretions away.
Cough/airway clearance: PATIENTS who are able to close the glottis and build subglottic pressure can
have natural cough strength restored and thereby need less invasive suction PROCEDURES.
Smell and taste: Tracheotomised PATIENTS usually lose the ability to smell and taste due to a lack of
airflow through the nasal and oral cavities. Use of a speaking valve re‐establishes this airflow
during exhalation and as a result, olfaction is stimulated.[40] Restoration of olfaction can also
facilitate the sense of taste. In turn, PATIENTS can experience improvement in appetite, which can
lead to increased oral intake and improved nutritional status.
Toileting: A closed glottis makes a Valsalva manoeuvre possible. This manoeuvre is used for toileting,
upper body strength (e.g. grunting to push yourself out of a chair or lift a heavy object) and to help
balance for safer ambulation.
Overall quality of life: A tracheostomy can raise many psychological/quality of life issues for PATIENTS.
Difficulty with communication, as well as secretion management and swallowing problems, can
discourage PATIENTS from attempting to socialize or interact with others. When using a speaking
valve, PATIENTS can breathe, speak, and use their hands more normally without drawing attention to
the tracheostomy. PATIENTS can use an ascot or scarf to cover the tracheostomy tube from sight if
they wish to do so. Restoration of normal speech, reduced suctioning requirements, and improved
swallowing facilitate return to a more normal lifestyle. PATIENTS can function without feeling
disabled and conspicuous because of their tracheostomy. Increased communicative ability can
enable PATIENTS to regain control over their environment and facilitate an improvement in self‐
esteem and well‐being.
Alternative monitoring and ALARM CONDITIONS: For all of the above quality of life reasons, it can be
preferable to deflate the tracheostomy tube cuff in stable, mechanically ventilated PATIENTS. In such
cases, it is important to provide alternative monitoring and associated ALARM CONDITIONS that can
aid in detecting significant increases in leak or circuit disconnect and then alert the caregiver to
those situations. None of these methods can provide direct replacement of exhaled volume
monitoring and the associated ALARM CONDITIONS, but this part of ISO 80601 permits the monitoring
of expiratory end‐tidal CO2 (201.12.1.104) or the detection of high leakage (201.12.4.111).
201.12.4.104 Expiratory end-tidal CO2 MONITORING EQUIPMENT

The monitoring of expiratory end‐tidal CO2 is employed clinically as a surrogate for arterial CO2 tension.
It therefore provides an alternative to monitoring expired tidal volume in assessing the adequacy of
ventilation of the lungs. However, in the event of an occlusion or leak within the VBS, minute ventilation
can be significantly reduced, while arterial CO2 rises. This can result in end‐tidal CO2 monitored values
that remain within the clinically acceptable range as the PATIENT tidal volume is reduced below the level
of physiologic dead space. The committee did not believe that safety could be ensured through use of
monitoring of end‐tidal CO2 unless either monitoring DELIVERED VOLUME or expired volume was also in
use.
It is not intended that this constrain a MANUFACTURER to integrate the CO2 MONITORING EQUIPMENT into the
VENTILATOR. However, when it is not integrated, a FUNCTIONAL CONNECTION between the CO2 MONITORING
EQUIPMENT and the VENTILATOR is required in order to ensure that the CO2 MONITORING EQUIPMENT is in
use. For the purpose of the TYPE TEST, the MANUFACTURER is expected to demonstrate that there is a
FUNCTIONAL CONNECTION between the VENTILATOR and end‐tidal CO2 MONITORING EQUIPMENT, such that the
resulting ME SYSTEM complies with the requirements of this part of ISO 80601. This allows for cases such

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ISO 80601-2-72:2015(E)
as when the end‐tidal CO2 MONITORING EQUIPMENT is integrated within a vital signs monitor from a
separate MANUFACTURER.
201.12.4.105 MAXIMUM LIMITED PRESSURE PROTECTION DEVICE
The value chosen for the MAXIMUM LIMITED PRESSURE[26][33] is a compromise between the need to avoid
barotrauma and the need to provide an adequate range of pressure to meet the desire of OPERATORS
specifically to supply high insufflation pressures for paediatric PATIENTS. 90 hPa is required to permit a
PATIENT to perform breathe stacking thereby avoiding the need for frequent suctioning.
201.12.4.107 Obstruction ALARM CONDITION

Sustained elevated AIRWAY PRESSURE levels can cause hazardous increases in intra‐thoracic pressure.
Such pressure increases can result in decreased venous return, reduced cardiac output, and a
subsequent drop in arterial blood pressure. Obstruction of the expiratory limb is the most common
obstruction in a VENTILATOR. The obstruction of expiratory limb ALARM CONDITION should be designed to
detect promptly a reduced expiratory flow due to an increased resistance in the expiratory limb.
The nature or duration of an occlusion in the expiratory limb of the VBS cannot be predicted. Assuming
that the occlusion is severe and the safety valve opens quickly, the PATIENT is not exposed to potentially
injurious high pressures, although at the likely expense of the loss of PEEP. Further inspirations, whether
or not assisted by the VENTILATOR, necessitate REBREATHING the previously exhaled gas trapped in the
inspiratory limb. Given these considerations and their consequences, the associated ALARM CONDITION is
required to be at least MEDIUM PRIORITY. Even if the VENTILATOR is highly sophisticated, the presence of an
occlusion in the expiratory limb of the VBS can compromise the VENTILATOR’S ability to provide essential
respiratory support to the PATIENT, which requires prompt action by the OPERATOR.
Causes of continuing AIRWAY PRESSURE include a malfunctioning expiratory valve, kinked tubing, and
expiratory filter blockage. Nebulised drugs can block expiratory filters within a short time.
Other consequences of incomplete expiration (increased peak AIRWAY PRESSURE or decreased
ventilation) can be detected and indicated by other ALARM CONDITIONS required by this part of
ISO 80601. Practice shows that clinically used ALARM LIMITS are not always sensitive enough to provide
early and specific detection of this potentially HAZARDOUS SITUATION.
201.12.4.108 Partial-occlusion ALARM CONDITION
Total obstruction of the expiratory gas pathway that immediately leads to an increased end‐expiratory
pressure is detected and acted on as indicated in 201.12.4.107. In this circumstance, the opening of an
inspiratory safety valve is also required. More commonly, the underlying causes responsible for total
obstruction can also cause a partial obstruction (e.g. minor kinking of the expiratory hose) or a slowly
increasing resistance (e.g. due to slow build‐up of nebulised aerosols on an expiratory BREATHING SYSTEM
FILTER, dependent on the filter material and the composition of the nebulised drug).
Partial obstruction not only leads to PATIENT discomfort (increased expiratory work of breathing,
missing triggers), but can develop into total obstruction. It is therefore desirable to detect and alert the
OPERATOR to increased resistance of the expiratory limb as early as possible to give the OPERATOR
sufficient time for remedy without interrupting ventilation.
This part of ISO 80601 does not specify the degree of obstruction that should be detected or the priority
of the partial obstruction ALARM CONDITION. The sensitivity that can be achieved without generating
FALSE POSITIVE ALARM CONDITIONS not only depends on the design of the VENTILATOR, but also on the
characteristics of the individual PATIENT. Therefore, the committee came to the conclusion that it is not
desirable to be more specific.
201.12.4.111 High leakage ALARM CONDITION
The high leakage TECHNICAL ALARM CONDITION is permitted to be used as a surrogate for expired volume
monitoring and its associated ALARM CONDITIONS. The MANUFACTURER needs to ensure that the high
leakage TECHNICAL ALARM CONDITION is robust and thereby proven to provide a reasonably safe

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ISO 80601-2-72:2015(E)
alternative. It is suggested that a combination of flow, time, and pressure monitoring along with pattern
recognition be utilized to determine if high leakage has occurred.
201.12.101 Protection against accidental adjustments
Unacceptable RISKS to the PATIENT can occur as a result of accidental adjustments of operating controls
or turning off the VENTILATOR. To control this RISK, the OPERATOR‐EQUIPMENT INTERFACE should be
designed to prevent accidental adjustments. The USABILITY ENGINEERING PROCESS is used to ensure that
these RISKS are reduced to acceptable levels. Example methods could include mechanical RISK CONTROL
techniques such as locks, shielding, friction loading and detents; pressure‐sensitive finger pads;
capacitive finger switches; and microprocessor‐oriented “soft” RISK CONTROLS or a specific sequence of
key or switch operations.
201.13.2.101 Additional specific SINGLE FAULT CONDITIONS
Operation of a VENTILATOR without an OPERATOR‐detachable BREATHING SYSTEM FILTER in place is
considered reasonably foreseeable when considering those parts of the VBS that might become
contaminated with body fluids or expired gases. If a VENTILATOR can operate without the BREATHING
SYSTEM FILTER, then one should assume that it has been operated without the BREATHING SYSTEM FILTER
and therefore, those parts of the VBS have been contaminated. Additional information is also found in
the rationale for 201.11.6.6.
201.13.102 Independence of ventilation control functions and related RISK CONTROL measures
This requirement prevents the use of a monitoring device to control an actuator that would lead to an
undetected malfunction of the actuator in case of monitoring failure.
201.101.2.1 General
Non‐standard VBS connectors can represent an unacceptable RISK as attempts are made to fit a standard
VBS to a VENTILATOR in an emergency situation. Non‐standard VBS connectors can cause leaks if used with
similar but not compatible connectors.
The use of Luer taper or Luer‐lock connectors complying with ISO 594‐1 or ISO 594‐2 are not permitted
for use in a VBS as there are several case reports of accidental connection with intravenous fluids and
parenteral and enteral feeding solutions causing serious morbidity and mortality due to aspiration of
these foreign substances into the lungs.
201.101.2.2.3 MANUAL VENTILATION PORT
Although provision for the manual ventilation of the PATIENT in cases of emergency is strongly
encouraged, the committee decided that this should be by means of a connection into the detachable
part of the VENTILATOR BREATHING SYSTEM or at the PATIENT CONNECTION PORT. It was decided that the use
of a connection port on the VENTILATOR could lead to misuse or confusion, with no compensating
advantage.
201.102.1 General
It is the responsibility of the MANUFACTURER of a VENTILATOR BREATHING SYSTEM, its parts, or ACCESSORIES to
VERIFY that their product complies with the requirements of this part of ISO 80601 by testing their
product, in combination with the other items for which compatibility is claimed, to the requirements of
this part of ISO 80601.
201.102.4 Humidification
Water management refers to the complete PROCESS by which moisture, in the form of water vapour, is
added to the breathing gas delivered to the PATIENT’S lungs and the PROCESS by which humidified
breathing gas is conducted back to the VENTILATOR’S expiratory system and exhausted to the room.
Intrinsic to this PROCESS is the necessity to remove bulk water due to condensation of moisture
attributable to pressure and temperature changes in the VBS. Even if breathing gas reaches the PATIENT‐
CONNECTION PORT without any added moisture, the expired breathing gas directed back to the VENTILATOR

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ISO 80601-2-72:2015(E)
contains a finite quantity of moisture. Water management in the VBS requires attention, whether or not
the VBS contains an active HUMIDIFIER, with or without heated wires in the inspiratory or the expiratory
limbs of the VBS, or a passive or an active HME at the PATIENT‐CONNECTION PORT.
Proper management of the PATIENT’S airway secretions and mucociliary transport system requires that
the VENTILATOR compensate for the humidity deficit caused by intubation, which bypasses the upper
airways where the normal humidification PROCESS would begin. Excess moisture delivered to the
PATIENT‐CONNECTION PORT can flood the cilia located in the bronchial airways, diminishing their ability to
move mucus toward the trachea. On the other hand, insufficient humidification of the inspired
breathing gas dries the bronchial airways, which leads to thickening of the mucous secretions and likely
increased airway resistance or worse. A balanced approach to humidification is needed to maintain
healthy cilia. Liquefied mucus can be readily aspirated using a SUCTION CATHETER.
Optimal humidification of the PATIENT’S airways results from an understanding of the physics of the
techniques chosen to add water vapour to the inspiratory gas stream. Depending on the system selected
for delivering humidified breathing gas to the PATIENT (for example, an active vapour HUMIDIFIER with or
without heated wires, conventional HME or active HME), condensate can accumulate in the inspiratory
limb of the VBS. If condensation occurs, the VBS needs to provide a method by which the liquid can be
removed.
In all but the most unusual circumstances, gas leaving the alveoli is saturated at 37 °C. Rainout persists
as the moist gas cools and moves toward the PATIENT‐CONNECTION PORT and is conducted back to the
VENTILATOR. If an HME is fitted at the PATIENT‐CONNECTION PORT, approximately 50 % to 70 % of the water
vapour will be trapped in the HME. Whatever the configuration of the expiratory limb of the VBS, the
water vapour content of the exhaled gas is significant, nearing saturation. Without heated wires, the
returning gas cools, causing significant condensation. As in the inspiratory limb, this liquid needs to be
removed. The presence of heated wires in the expiratory limb lessens or eliminates condensation
before the expired gas enters the GAS RETURN PORT of the VENTILATOR, but from this point to the EXHAUST
PORT, the gas tends to cool further, so more moisture condenses. The VBS needs to include some means
to manage this additional condensed water.
201.102.6.2 Non-invasive ventilation
The inaccuracies are due to the nature of the non‐intentional leaks (such as those that occur when a
PATIENT'S mouth opens when on a nasal MASK or when the MASK seal begins leaking when the pressure
inside reaches a certain level).
201.103 Spontaneous breathing during loss of power supply
A previous version of this standard (ISO 10651‐2:2004) required disclosure of the resistance under
failure conditions. The committee concluded that a PATIENT in this state can breathe spontaneously
under these conditions until alternative ventilation is provided. Previous standards for VENTILATORS
have required that the pressure drop be less than 6 hPa (6 cmH2O) at 60 l/min for adults. Spontaneous
breathing is only needed to bridge the time until alternative ventilation is provided. The committee
came to the conclusion that a mere disclosure is not sufficient. The chosen values are regarded as more
realistic and sufficient for this infrequent event and were tailored to the intended range of DELIVERED
VOLUMES.
201.104 Training
The modern VENTILATOR is complex equipment whose use requires specific training for each
MANUFACTURER'S make and model. Different MANUFACTURERS often refer to similar modes of ventilation
by different names and although in principle, those modes are similar to those of another
MANUFACTURER'S VENTILATOR, their modes are unique in sometimes minor and sometimes complex ways.
It is essential, therefore, that the LAY OPERATOR and every person involved in the operation and setup of
a VENTILATOR is fully trained in that VENTILATOR’S operational characteristics; in particular, its controls,
capabilities, and limitations, prior to any use.

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201.105 Indication of duration of operation

VENTILATORS require maintenance for continued safe use. A practicable means to ensure that this
information is available to the OPERATOR or the RESPONSIBLE ORGANIZATION is to require that the
VENTILATOR keep track of how long it has been in operation.
201.106.2 Connection to electronic health record

Electronic documentation of PATIENT care interventions is rapidly becoming the standard of care. The
primary motivations are to improve the quality of care for an individual PATIENT through accurate and
complete documentation and to improve the completeness and accuracy of aggregate data to facilitate
continuous quality improvement. Providing remote supervisory capability is rapidly becoming the
standard of care in the HOME HEALTHCARE ENVIRONMENT.
201.106.3 Connection to DISTRIBUTED ALARM SYSTEM
PATIENTS who are VENTILATOR‐dependent are not always located near enough to the LAY OPERATOR to
ensure that ALARM SIGNALS coming from the PATIENT'S room can be heard. It is reasonably foreseeable
that some rooms of a PATIENT’S home or limited care facility are out of earshot of other rooms. As a
result, it is necessary for a VENTILATOR intended for use in the HOME HEALTHCARE ENVIRONMENT to be
equipped with a means to connect to a DISTRIBUTED ALARM SYSTEM that can provide additional ALARM
SIGNAL presentation points. A DISTRIBUTED ALARM SYSTEM facilitates delivery of ALARM SIGNALS to other
rooms where the OPERATOR might be located, thereby permitting a timely response and intervention to
support PATIENT care.
202.4.3.1 Compliance criteria
It is not the intent of the committee to require that the IMMUNITY tests be performed multiple times (e.g.
with volume‐controlled breath type and pressure‐controlled breath type at several DELIVERED VOLUMES),
but that the MANUFACTURER should determine which breath type and DELIVERED VOLUME represents the
worst‐case for a given IMMUNITY test and use those conditions.
The committee considered whether a pressure error acceptance criterion was necessary. For a given set
of test conditions and parameters, the compliance and resistance are fixed. As a result, an error in
pressure is reflected as an error in DELIVERED VOLUME. Therefore, the committee considers the DELIVERED
VOLUME acceptance criteria sufficient.
208.6.8.4.101 Additional requirements for termination of ALARM SIGNAL inactivation

Permitting very long pauses of ALARM SIGNALS can be hazardous for the PATIENT since the OPERATOR will
not be notified of the existence of an ALARM CONDITION. However, PATIENT management often requires
PROCEDURES that can be disrupted by auditory ALARM SIGNALS. Therefore, extending AUDIO PAUSED by
OPERATOR action is useful to prevent the VENTILATOR from disturbing the OPERATOR or others in the
vicinity.
VENTILATORS should be equipped with an AUDIO PAUSED capability that permits the OPERATOR to pause the
ALARM SIGNALS prior to the creation of an ALARM CONDITION. Such a capability permits the OPERATOR to
minimize nuisance auditory ALARM SIGNALS in situations that are known to be associated with creation of
nuisance ALARM CONDITIONS. A ‘planned’ disconnect is a common situation where this capability is
needed. Examples include open suctioning, BREATHING SYSTEM FILTER change, or insertion of a medication
treatment. A closed suctioning mode should also include such a capability.
208.6.12.101 Additional requirements for ALARM SYSTEM logging
Optimal management of a PATIENT requires the ability to review the history of important ALARM
CONDITIONS. This is a more reasonable means of RISK CONTROL in the HOME HEALTHCARE ENVIRONMENT for
life‐supporting equipment than LATCHING ALARM SIGNALS. Additional information is also found in
IEC 60601‐1‐8:2006+AMD1:2012, Annex A, for 6.12 – ALARM CONDITION logging.

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ISO 80601-2-72:2015(E)
211.8.4.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to

ME EQUIPMENT
Two hours was chosen as the minimum acceptable time necessary to ensure that alternative
arrangements could be made to continue the life‐supporting function. Climatic, traffic, and other
conditions require at least this period before restoration of power or arrangement for other supplies.

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ISO 80601-2-72:2015(E)
Annex BB
(informative)
Data interface requirements
BB.1 Background and purpose

Heightened interest in the monitoring of VENTILATORS, as well as accountability and responsiveness of
the parties involved, has become evident on an international scale. Consequently, PATIENTS, caregivers,
clinicians, service providers, and payers have begun the systematic definition and collection of
information with regard to monitoring the performance of this type of VENTILATOR. This trend is also
driven by an enhanced data infrastructure. In order to establish a common definition for monitoring the
ventilatory performance of the VENTILATOR, explicit criteria need be applied to choosing and defining
parameters. This framework is intended to inform about a common definition of parameters for
VENTILATORS. The selection is based on some agreement about what is to be monitored and for what
purpose.
It is important to note that any data collection needs to be carried out according to privacy and
confidentiality legislation and ethical principles.
A harmonized effort to develop internationally accepted therapy indicators for VENTILATORS not only
fosters increasingly robust cross‐national analyses, but can also facilitate the development of
comparable data that can be used as a basis for the setting of international benchmarks.
The standardization of data available from VENTILATORS is intended to help to eliminate the current
shortcomings and significantly contribute to the improvement of the therapy. This approach seeks to
provide a definition that can be used across VENTILATOR therapy systems for providing therapy data
independent of VENTILATOR MANUFACTURER or what mechanisms are used to transport the data, either
locally or remotely to a healthcare professional. This approach ensures comparability between data
regardless of the transport mechanism chosen to be most appropriate for a PATIENT situation. It also
provides for flexible and cost‐effective integration into disparate systems that healthcare professionals
can use for PATIENT data management. This approach also maintains comparability between data while
allowing advancement in data transport technology to provide solutions that better meet the needs of
PATIENTS, caregivers, clinicians, service providers, and payers. As such, the definition of specific device
communication interface hardware or software considerations such as protocols or transport mediums
is outside of the scope of this part of ISO 80601.
A number of monitoring requirements exist for VENTILATORS, depending on the needs of the PATIENT,
caregiver, clinician, service provider, and payer, which require various levels of data. This part of
ISO 80601 seeks to define the data that for VENTILATORS that are required to provide to meet the
objectives of these users.
The following levels of data are defined.
— Parameters and units of measurement: Parameters and units of measurement used in the
VENTILATOR
— Equipment identification: Information identifying the VENTILATOR
— Usage monitoring: Temporal data relating to the use of the VENTILATOR
— Equipment settings: The different therapy modes provided by VENTILATORS that require different
settings

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ISO 80601-2-72:2015(E)
— Ventilation monitoring: Settings relating to PATIENT ventilation
— VENTILATOR ALARM LIMITS: Settings relating to ventilation‐related ALARM LIMITS
— Event information: Information provided about events related to the usage of the VENTILATOR
— Service monitoring: Indicators relating to preventative or corrective maintenance of the

VENTILATOR and its ACCESSORIES
All therapy systems should provide the information to enable identification of the VENTILATOR.
Implementation of any further data levels is optional.
Information identifying pressure units used in the data set should also be provided.
BB.2 Data definition
Table BB.101 defines information, which identifies units of measurement in the data set.
Table BB.101 — Parameters and units of measurement

Parameter Description Type
Pressure units Specification of the units of measurement for Value: (cmH2O or hPa)
pressure‐related data
Flowrate units Specification of the units of measurement for Value: (l/min or l/s)
flowrate related data
Volume units Specification of the units for flow related data Value: (ml or l)
Frequency units Specification of the units for frequency Value: (breaths/min)
INSPIRATORY TIME units Specification of the units for INSPIRATORY TIME Value: (s)
Leakage units Specification of the units for leakage Value: (ml/min)
Table BB.102 defines VENTILATOR identification data.
Table BB.102 — Equipment identification

Equipment MANUFACTURER Identification of the MANUFACTURER of the equipment Text string
Equipment model Identification of the product or model number of Text string
the equipment
Equipment serial number Identification number of the equipment Text string
Equipment software Identification of the software version(s) Text string
version implemented in the equipment
NOTE More than one software version can be needed to be communicated from the equipment.
Table BB.103 defines data required for usage monitoring.
A set of measured and calculated values should be provided for each therapy session, where a therapy
session is any period of time the VENTILATOR is providing ventilation.

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Table BB.103 — Usage monitoring

Therapy start date/time The current UTC date and time when the usage ISO 8601 Date Time
session was started (YYYY‐MM‐DDThh:mm:ssZ
Therapy stop date/time The current UTC date and time when the usage ISO 8601 Date Time
session was stopped (YYYY‐MM‐DDThh:mm:ssZ
Hours of ventilation Number of hours the equipment is powered on and Value: (h)
providing ventilation for the usage session
Hours of PATIENT use Number of hours the equipment is providing Value: (h)
therapy to the PATIENT for the usage session
Table BB.104 defines applicable current settings of the VENTILATOR for each mode of operation.
Table BB.104 — Equipment settings

Mode of operation Device breathing therapy mode as defined within Mode selected:
the standard (VCV, AVCV, PCV, APCV, PSV,
SIMV, CPAP)
PATIENT category Selected application category Mode selected:
(neonatal, paediatric, adult)
Mode of application Mode of application of the VBS on the Mode selected:
PATIENT/interface to the PATIENT (invasive, non‐invasive)
VENTILATOR BREATHING Type of VBS used Mode selected:
SYSTEM (VBS) (single limb with leakage
system, single limb with
controlled expiratory valve,
double limb with controlled
expiratory valve)
Language Identification of the user interface language Selection of supported
setting languages
Display brightness Setting of the luminous intensity as a percentage Decimal
of the maximum setting
Inspiratory therapy Setting of the inspiratory pressure Value: (cmH2O or hPa)
pressure
Expiratory therapy Setting of the expiratory pressure Value: (cmH2O or hPa)
pressure
Inspiratory trigger Setting of the inspiratory trigger type Mode selected:
sensitivity mode 1 = auto (1, 2, 3, 4, 5)
2 = pressure
3 = flow
4 = time
5 = MANUFACTURER‐specific
Inspiratory trigger Inspiratory trigger value by mode Value:
sensitivity 1 (none)
2 (cmH2O or hPa)
3 (l/min)
4 (ms or %)
5 (List of text strings
MANUFACTURER‐defined)

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Table BB.104 (continued)

Expiratory trigger Setting of the expiratory trigger type Mode selected:
sensitivity mode 1 = auto (1, 2, 3, 4, 5)
2 = pressure
3 = flow
4 = time
5 = MANUFACTURER‐specific
Expiratory trigger Expiratory trigger value by mode Value:
sensitivity 1 (none)
2 (cmH2O or hPa)
3 (l/min)
4 (ms or %)
5 (List of text strings
MANUFACTURER‐defined)
Tidal volume Setting of the inspiratory tidal volume Value: (ml)

Inspiratory flow waveform Setting of the inspiratory flow waveform Mode selected:
(Square, decelerated)
Inspiratory slope Setting of the inspiratory slope Mode selected: (1, 2, 3)
PEEP POSITIVE END‐EXPIRATORY PRESSURE Value: (cmH2O or hPa)
Breathing frequency Frequency of the ventilatory cycle Value: (breaths/min)
I:E ratio Ratio of the inspiratory / expiratory duration Value: (I:E)
INSPIRATORY TIME Duration of the inspiratory part of the cycle Value: (s)
Inspiratory percentage of Percentage of the inspiratory part of the complete Value: (%)
the inspiratory cycle ventilatory cycle
Maximum inspiratory Maximum inspiratory breathing therapy pressure Value: (cmH2O or hPa)
therapy pressure
Sigh activated Information if the sigh function is activated Mode selected: (yes/ no)
Sigh period Duration of the sigh period Value: (s)
Sigh frequency Frequency of the sigh Value: (cycles/min)
Target tidal volume Target volume the delivered tidal volume should Value: (ml)
reach
Apnoea duration limit Maximum duration of an apnoea until a tidal Value: (s)
volume is delivered
Apnoea frequency limit Maximum frequency of apnoea occurring Value: (cycles/min)
Apnoea tidal volume Tidal volume delivered if apnoea has been Value: (ml)
identified
O2 measurement Information about the activation of the inspiratory Boolean
activation oxygen measurement (True if activated otherwise,
false)
Expiratory volume Information about the activation of the expiratory Boolean
measurement activation tidal volume measurement (True if activated otherwise,
false)

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Table BB.105 defines the indicators relating to monitoring of PATIENT ventilation.
Table BB.105 — Ventilation monitoring

High inspiratory pressure Highest pressure during the inspiratory phase of Value: (cmH2O or hPa)
the breathing cycle
Low inspiratory pressure Lowest pressure during the inspiratory phase of the Value: (cmH2O or hPa)
breathing cycle
High FiO2 Highest inspiratory oxygen concentration Value: (% O2 V/V)
Low FiO2 Lowest inspiratory oxygen concentration Value: (% O2 V/V)
High inspiratory tidal Highest inspiratory tidal volume delivered by the Value: (ml)
volume VENTILATOR
Low inspiratory tidal Lowest inspiratory tidal volume delivered by the Value: (ml)
volume VENTILATOR
High expiratory tidal Highest expiratory tidal volume delivered by the Value: (ml)
volume VENTILATOR
Low expiratory tidal Lowest expiratory tidal volume delivered by the Value: (ml)
volume VENTILATOR
High inspiratory minute Highest inspiratory minute volume delivered by the Value: (ml)
volume VENTILATOR
Low inspiratory minute Lowest inspiratory minute volume delivered by the Value: (ml)
volume VENTILATOR
High expiratory minute Highest expiratory minute volume delivered by the Value: (ml)
volume VENTILATOR
Low expiratory minute Lowest expiratory minute volume delivered by the Value: (ml)
volume VENTILATOR
Highest rate of respiratory breathing cycles Value: (cycles/min)

High Respiratory Rate
delivered by the VENTILATOR
Lowest rate of respiratory breathing cycles Value: (cycles/min)
Low Respiratory Rate
delivered by the VENTILATOR
Table BB.106 defines the applicable current ALARM LIMITS of the VENTILATOR.
Table BB.106 — VENTILATOR ALARM LIMITS

High inspiratory pressure Setting of the high pressure during the inspiratory Value: (cmH2O or hPa)
ALARM CONDITION phase of the breathing cycle ALARM LIMIT
Low inspiratory pressure Setting of the low pressure during the inspiratory Value: (cmH2O or hPa)
ALARM CONDITION phase of the breathing cycle ALARM LIMIT
High FiO2 ALARM CONDITION Setting of the high inspiratory oxygen concentration Value: (% O2 V/V)
ALARM LIMIT
Low FiO2 ALARM CONDITION Setting of the low inspiratory oxygen concentration Value: (% O2 V/V)
ALARM LIMIT

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Table BB.106 (continued)

High inspiratory tidal Setting of the high inspiratory tidal volume Value: (ml)
volume ALARM CONDITION delivered by the VENTILATOR ALARM LIMIT
Low inspiratory tidal Setting of the low inspiratory tidal volume delivered Value: (ml)
volume ALARM CONDITION by the VENTILATOR ALARM LIMIT
High expiratory tidal Setting of the high expiratory tidal volume delivered Value: (ml)
Low expiratory tidal Setting of the low expiratory tidal volume delivered Value: (ml)
High inspiratory minute Setting of the high inspiratory minute volume Value: (ml/min)
Low inspiratory minute Setting of the low inspiratory minute volume Value: (ml/min)
High expiratory minute Setting of the high expiratory minute volume Value: (ml/min)
Low expiratory minute Setting of the low expiratory minute volume Value: (ml/min)
High respiratory rate Setting of the high rate of respiratory breathing Value: (cycles/min)
ALARM CONDITION cycles delivered by the VENTILATOR ALARM LIMIT
Low respiratory rate Setting of the low rate of respiratory breathing Value: (cycles/min)
ALARM CONDITION cycles delivered by the VENTILATOR ALARM LIMIT
Table BB.107 defines applicable VENTILATOR usage information.
Table BB.107 — Event information

Power supply source Current source of electrical power Mode in use: (1, 2, 3)
1 = external AC SUPPLY MAINS
2 = INTERNAL ELECTRICAL POWER SOURCE
3 = external DC SUPPLY MAINS
ALARM SIGNAL inactive state List of text strings List of text strings
present (ALARM OFF, ALARM PAUSE, AUDIO OFF, AUDIO PAUSE,
ACKNOWLEDGED)
Active ALARM CONDITION Currently active ALARM CONDITIONS List of text strings
(MANUFACTURER‐defined)
Access mode Current access mode of the VENTILATOR Mode in use: (1, 2, 3)
1 = LAY OPERATOR
2 = supervising clinician or the healthcare
professional OPERATOR
3 = RESPONSIBLE ORGANIZATION

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Table BB.108 defines applicable service and maintenance parameters.
Table BB.108 —Service monitoring

Maintenance needed A MANUFACTURER‐specific list of any items requiring List of text strings
Maintenance, e.g. MASK, tubing, filter (MANUFACTURER‐defined)
VENTILATOR service An indication that service is required Text string:
indicator (MANUFACTURER‐defined)

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Annex CC
(informative)
Reference to the essential principles
This document has been prepared to support the essential principles of safety and performance of a
VENTILATOR, its ACCESSORIES, or parts as medical devices according to ISO/TR 16142:2006. This
document is intended to be acceptable for conformity assessment purposes.
Compliance with this document provides one means of demonstrating conformance with the specific
essential principles of ISO/TR 16142:2006. Other means are possible. Table CC.1 maps the clauses and
subclauses of this document with the essential principles of ISO/TR 16142:2006.
Table CC.1 — Correspondence between this document and the essential principles
Essential principle of Corresponding clause(s)/sub- Qualifying remarks/Notes

ISO/TR 16142:2006 clause(s) of this document
A.1, A.2, A.3 all
A.4 201.4, 201.7, 201.15, 201.12.1,
201.102
A.5 201.4, 201.7, 201.15, 201.12.1,
201.102
A.6 201.4, 201.7, 201.15, 201.12.1,
201.102
A.7.1 201.4, 201.7, 201.15, 201.12.1,
201.102
A.7.2 201.11.6.4, 201.11.6.6
A.7.3 201.11.6.4, 201.11.6.6
A.7.5 201.11.6.4
A.7.6 201.11
A.8.1 201.11.6.6, 201.11.6.7
A.8.2 201.11.6.7
A.8.5 201.7.2.17.101
A.9.1 201.4.6, 201.4.11, 201.7.2.4.101,
201.7.2.13.101, 201.7.2.17.101,
201.7.2.101, 201.7.9.2.2.101,
201.7.9.2.5.101, 201.7.9.2.14.101,
201.12.1.102, 201.12.1.103, 201.16,
201.101, 201.102, 201.106
A.9.2 201.4.11.101, 201.9, 202, 206, 211
A.9.3 201.11
A.10.1 201.12.1, 201.102
A.10.2 201.7, 201.12.1, 206, 208
A.10.3 201.7.4.3

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Table CC.1 (continued)
Essential principle of Corresponding clause(s)/sub- Qualifying remarks/Notes

ISO/TR 16142:2006 clause(s) of this document
12.1 201.14
12.1 a) 201.14
A.12.1 201.14
A.12.5 202
A.12.6 201.8
A.12.7.1 201.9
A.12.7.2 201.9
A.12.7.3 201.9
A.12.7.4 201.8, 201.15, 201.101.1, 201.101.2
A.12.7.5 201.11
A.12.8.1 201.12.1
A.12.8.2 201.12.4
A.12.8.3 201.7, 206
A.13.1 201.7, 201.11.6.4

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Annex DD
(informative)
Alphabetized index of defined terms used in this particular standard
NOTE The ISO Online Browsing Platform (OBP) provides access to terms and definitions. 10
Term Source
ACCESSIBLE PART IEC 60601‐1:2005, 3.2
ACCESSORY IEC 60601‐1:2005, 3.3
ACCOMPANYING DOCUMENT IEC 60601‐1:2005, 3.4
ACKNOWLEDGED IEC 60601‐1‐8:2006+AMD1:2012, 3.37
AIRWAY PRESSURE (PAW) 201.3.201
ALARM CONDITION IEC 60601‐1‐8:2006+AMD1:2012, 3.1

ALARM CONDITION DELAY IEC 60601‐1‐8:2006, 3.2
ALARM LIMIT IEC 60601‐1‐8:2006, 3.3
ALARM OFF IEC 60601‐1‐8:2006, 3.4
ALARM PAUSED IEC 60601‐1‐8:2006, 3.5
ALARM SETTINGS IEC 60601‐1‐8:2006, 3.6
ALARM SIGNAL IEC 60601‐1‐8:2006, 3.7
ALARM SYSTEM IEC 60601‐1‐8:2006, 3.8
ANAESTHETIC GAS SCAVENGING SYSTEM ISO 4135:2001, 7.1.1
APPLIANCE COUPLER IEC 60601‐1:2005, 3.6
APPLIANCE INLET IEC 60601‐1:2005, 3.7
APPLIED PART IEC 60601‐1:2005, 3.8
AUDIO OFF IEC 60601‐1‐8:2006, 3.12
AUDIO PAUSED IEC 60601‐1‐8:2006, 3.13
BASIC SAFETY IEC 60601‐1:2005, 3.10
BREATHING SYSTEM FILTER 201.3.202
BSF 201.3.202
CLEARLY LEGIBLE IEC 60601‐1:2005+AMD1:2012, 3.15
DELIVERED VOLUME (VDEL) 201.3.203
DETACHABLE POWER SUPPLY CORD IEC 60601‐1:2005, 3.21
10 Available at https://www.iso.org/obp/ui/#home

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Term Source
DISTRIBUTED ALARM SYSTEM IEC 60601‐1‐8:2006, 3.17
ESSENTIAL PERFORMANCE IEC 60601‐1:2005+AMD1:2012, 3.27
EXHAUST PORT 201.3.204
EXPECTED SERVICE LIFE IEC 60601‐1:2005+AMD1:2012, 3.28
FALSE POSITIVE ALARM CONDITION IEC 60601‐1‐8:2006, 3.21
FUNCTIONAL CONNECTION IEC 60601‐1:2005, 3.33
FLOW‐DIRECTION‐SENSITIVE COMPONENT 201.3.205
FRESH GAS 201.3.206
GAS INTAKE PORT 201.3.207
GAS OUTPUT PORT 201.3.208
GAS RETURN PORT 201.3.209
HARM IEC 60601‐1:2005, 3.38
HAZARD IEC 60601‐1:2005, 3.39
HAZARDOUS SITUATION IEC 60601‐1:2005, 3.40
HIGH PRIORITY IEC 60601‐1‐8:2006, 3.22
HIGH‐PRESSURE INPUT PORT 201.3.210
HME ISO 4135:2001, 7.1.1
HEAT AND MOISTURE EXCHANGER ISO 4135:2001, 7.1.1
HOME HEALTHCARE ENVIRONMENT IEC 60601‐1:2005, 3.2
HUMIDIFIER ISO 8185:2007, 3.8
IMMUNITY (to a disturbance) IEC 60601‐1‐2:2015, 3.8
INSPIRATORY TIME (tI) ISO 4135:2001, 3.4.13
INTENDED USE IEC 60601‐1:2005+AMD1:2012, 3.44

INTELLIGENT ALARM SYSTEM IEC 60601‐1‐8:2006, 3.24
INTERNAL ELECTRICAL POWER SOURCE IEC 60601‐1:2005, 3.45
LATCHING ALARM SIGNAL IEC 60601‐1‐8:2006, 3.26
LAY IEC 60601‐1‐11:2015, 3.3
LOW PRIORITY IEC 60601‐1‐8:2006, 3.27
MAINS CONNECTOR IEC 60601‐1:2005, 3.48
MANUFACTURER IEC 60601‐1:2005, 3.55
MANUAL VENTILATION PORT 201.3.211
MASK ISO 17510:2015, 3.4
MAXIMUM LIMITED PRESSURE (PLIM max) 201.3.212
ME EQUIPMENT (MEDICAL ELECTRICAL EQUIPMENT) IEC 60601‐1:2005, 3.63

ME SYSTEM (MEDICAL ELECTRICAL SYSTEM) IEC 60601‐1:2005, 3.64

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Term Source
MEDICAL GAS PIPELINE SYSTEM ISO 7396‐1:2007, 3.29
MEDIUM PRIORITY IEC 60601‐1‐8:2006, 3.28
MODEL OR TYPE REFERENCE IEC 60601‐1:2005, 3.66
MONITORING EQUIPMENT 201.3.213
NOMINAL (value) IEC 60601‐1:2005, 3.69
NORMAL CONDITION IEC 60601‐1:2005, 3.70
NORMAL USE IEC 60601‐1:2005, 3.71
OPERATOR IEC 60601‐1:2005, 3.73
OPERATOR‐EQUIPMENT INTERFACE IEC 60601‐1‐6:2010, 3.1
PATIENT IEC 60601‐1:2005+AMD.1:2012, 3.76
PATIENT‐CONNECTION PORT 201.3.214
PEEP 201.3.215
POSITIVE END‐EXPIRATORY PRESSURE 201.3.215
POWER SUPPLY CORD IEC 60601‐1:2005, 3.87
PRIMARY OPERATING FUNCTION IEC 62366‐1:2015, 3.11
PROCEDURE IEC 60601‐1:2005+AMD1:2012, 3.88
PROCESS IEC 60601‐1:2005+AMD1:2012, 3.89
PEMS (PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS) IEC 60601‐1:2005, 3.90
PESS (PROGRAMMABLE ELECTRONIC SUBSYSTEM) IEC 60601‐1:2005, 3.91
PROTECTION DEVICE 201.3.216
RATED (value) IEC 60601‐1:2005, 3.97
RESIDUAL RISK IEC 60601‐1:2005+AMD1:2012, 3.100
RESPONSIBLE ORGANIZATION IEC 60601‐1:2005, 3.101
RISK IEC 60601‐1:2005, 3.102
RISK CONTROL IEC 60601‐1:2005+AMD1:2012, 3.105
RISK MANAGEMENT IEC 60601‐1:2005+AMD1:2012, 3.107
RISK MANAGEMENT FILE IEC 60601‐1:2005+AMD1:2012, 3.108
SINGLE FAULT CONDITION IEC 60601‐1:2005+AMD1:2012, 3.116
SOFTWARE ITEM IEC 62304:2006, 3.25
SUCTION CATHETER ISO 8836:2007, 3.8
SUPPLY MAINS IEC 60601‐1:2005, 3.120
TECHNICAL ALARM CONDITION IEC 60601‐1‐8:2006, 3.36
TOOL IEC 60601‐1:2005, 3.127
TRANSIT‐OPERABLE IEC 60601‐1‐11:2015, 3.6
TYPE TEST IEC 60601‐1:2005, 3.135
USABILITY IEC 62366‐1:2015, 3.16

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
Term Source
USABILITY ENGINEERING IEC 62366‐1:2015, 3.17
USABILITY ENGINEERING FILE IEC 62366‐1:2015, 3.18
VBS 201.3.218
VENTILATOR 201.3.217
VENTILATOR BREATHING SYSTEM 201.3.218
VENTILATOR FOR VENTILATOR‐DEPENDENT PATIENT 201.3.217
VERIFICATION (VERIFIED) IEC 60601‐1:2005+AMD1:2012, 3.138

BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
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BS EN ISO 80601-2-72:2015
ISO 80601-2-72:2015(E)
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BS EN ISO 80601-2-72:2015

BSI Standards Publication

Medical electrical equipment

ICS 11.040.10 Supersedes EN ISO 10651-2:2009

Medical electrical equipment - Part 2-72: Particular

This European Standard was approved by CEN on 7 May 2015.

EUROPEAN COMMITTEE FOR STANDARDIZATION

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

This document supersedes EN ISO 10651-2:2009.

Relationship between this Document and

Clause/subclause Corresponding essential Qualifying remarks/notes

Clause/subclause Corresponding essential Qualifying remarks/notes

Clause/subclause Corresponding essential Qualifying remarks/notes

Foreword .................................................................................................................................................................. vii

Introduction ................................................................................................................................................................... ix

iv © ISO 2015 – All rights reserved

201.16 ME SYSTEMS .................................................................................................................................................. 35

© ISO 2015 – All rights reserved v

211.10.1.1 General requirements for mechanical strength ........................................................................ 44

Annex D (informative) Symbols on marking ...................................................................................................... 52

vi © ISO 2015 – All rights reserved

ISO (the International Organization for Standardization) is a worldwide federation of national

The most significant changes are the following modifications:

— identification of ESSENTIAL PERFORMANCE for a VENTILATOR and its ACCESSORIES;

and the following additions:

— tests for ventilation performance;

— tests for mechanical strength (via IEC 60601‐1‐11);

© ISO 2015 – All rights reserved vii

— requirements for a VENTILATOR as a component of an ME SYSTEM;

— tests for ENCLOSURE integrity (water ingress via IEC 60601‐1‐11);

— tests for cleaning and disinfection PROCEDURES (via IEC 60601‐1‐11);

viii © ISO 2015 – All rights reserved

© ISO 2015 – All rights reserved ix

Medical electrical equipment — Part 2-72: Particular

201.1 Scope, object, and related standards

— intended for use by a LAY OPERATOR;

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only or to ME SYSTEMS

© ISO 2015 – All rights reserved 1

201.1.3 Collateral standards

2 © ISO 2015 – All rights reserved

— “Replacement” means that the clause or subclause of IEC 60601‐1:2005+AMD1:2012 or the

— “Amendment” means that the clause or subclause of IEC 60601‐1:2005+AMD1:2012 or the

IEC 60601‐1:2005+AMD1:2012, Clause 2 applies, except as follows:

© ISO 2015 – All rights reserved 3

IEC 61672‐1:2002, Electroacoustics — Sound level meters — Part 1: Specifications

3 To be replaced by ISO 80601‐2‐74.

4 © ISO 2015 – All rights reserved

© ISO 2015 – All rights reserved 5

[SOURCE: ISO 4135:2001, 4.2.1.6, modified—Deleted ‘excess and/or’.]

6 © ISO 2015 – All rights reserved

© ISO 2015 – All rights reserved 7

Table 201.101 — Distributed ESSENTIAL PERFORMANCE requirements

ALARM LIMITS set by the OPERATOR or

generation of an ALARM CONDITION

— the RATED range shall include at least 12,4 V to 15,1 V, and

— for operation from 24 V d.c. SUPPLY MAINS

8 © ISO 2015 – All rights reserved

— the RATED range shall include at least 24,8 V to 30,3 V, and

— for operation from other d.c. SUPPLY MAINS

201.4.11.101.2 Compatibility requirement

— under NORMAL CONDITION,

3) the ACCOMPANYING DOCUMENTS shall disclose the following:

© ISO 2015 – All rights reserved 9